{ "release_id": "2b2017b84496b985", "id": "cardio:omron-hem-907", "owner": "cardio", "kind": "product", "slug": "omron-hem-907", "name": "Omron HEM-907 blood pressure monitor", "aliases": [ "HEM-907", "Omron IntelliSense blood pressure monitor, model HEM-907" ], "atlases": [ "cardio" ], "summary_plain": "An electronic blood pressure monitor, the Omron HEM-907. The US Food and Drug Administration cleared it in 2000. The FDA record names Omron Healthcare, Inc. only as the applicant for that clearance and does not say who makes the monitor. A 2002 study of 33 people reported that it passed the test protocol the authors used. The FDA record does not say who the monitor is for or where it is used. STRIDE BP, an expert group that keeps lists of blood pressure monitors, has its own page for this model on its website. This atlas names and links that resource (see the STRIDE BP page) and does not restate its content, which is the group's own classification and not a finding of the FDA. Neither a clearance nor passing a test protocol tells you how accurate a monitor is for every person or in everyday use.", "summary_technical": "Listed in FDA 510(k) K001848 as OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907, decided 2000-07-03, product code DXN, device class 2, clearance type Special. The record is a Statement and gives no indications-for-use text. FDA's device type for the code is System, Measurement, Blood-Pressure, Non-Invasive. A 2002 paper (abstract only) reports that the device passed both phases of the international validation protocol in 33 people. FDA also lists a separate model, HEM-907XL, under K032305 (decided 2004-02-11). The SPRINT trial paper names its automated measurement system as \"Model 907, Omron Healthcare\" and does not say which variant. This atlas does not state which one SPRINT used. The STRIDE BP website has a page for this model. STRIDE BP's terms do not allow its content to be reproduced, so this atlas names and links that resource (see the STRIDE BP page) and restates none of its classification.", "editorial_state": "draft", "last_substantive_edit": "2026-10-13", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "navigation": { "cardio": { "system": [ "blood-vessels" ], "condition-area": [ "hypertension" ] } }, "payload": { "subtype": "device", "model_or_formulation": "HEM-907", "version": "Not stated in the sources read. FDA lists a separate model, HEM-907XL, under its own number.", "intended_use_snapshots": [] }, "content_digest": "7f1c5432cbcce8a1fccbc160197c6c1a2950b6c367a901f5722d5f6d80bab8df", "review": { "content_digest": "7f1c5432cbcce8a1fccbc160197c6c1a2950b6c367a901f5722d5f6d80bab8df", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "2b2017b84496b985", "id": "cardio:claim-fda-k001848-clearance", "owner": "cardio", "subject_entity_id": "cardio:omron-hem-907", "category": "regulatory", "statement": "The US Food and Drug Administration cleared the Omron IntelliSense blood pressure monitor, model HEM-907, under 510(k) number K001848 on 3 July 2000. The FDA record gives the decision as Substantially Equivalent and the clearance type as Special. It lists the product code DXN, device class 2 and regulation number 870.1130, and names Omron Healthcare, Inc. as the applicant.", "context": { "id": "cardio:ctx-fda-k001848-us-clearance", "label": "United States 510(k) clearance record K001848 for the Omron HEM-907", "recipient": "unknown", "population": "Not stated in the FDA record. The record names a device and an applicant, and gives no intended population.", "care_setting": "Not stated in the FDA record", "geography": "United States (decision by the US Food and Drug Administration)", "life_stage": "Not stated in the FDA record", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "The FDA record is a Statement, not a Summary, and no indications-for-use text was found, so the intended population and use are not stated here. The 510(k) PDF address returned HTTP 404 when fetched on 2026-10-11 (label ca-fda-k001848-pdf.html). This claim records the decision and the fields the FDA record gives. A clearance is not a finding about how accurate the monitor is for any person or in everyday use. It applies to the HEM-907 only: FDA lists the HEM-907XL as a separate model under a different number. openFDA's own disclaimer says \"Do not rely on openFDA to make decisions regarding medical care\".", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].k_number", "applicability_note": "The 510(k) number of this record.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].device_name", "applicability_note": "Names the model as HEM-907.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].applicant", "applicability_note": "The applicant, as FDA writes the name.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "ISO date. The FDA database page writes the same date as a month-first slash date.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_description", "applicability_note": "The decision wording used for a 510(k) clearance.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].clearance_type", "applicability_note": "The clearance type as FDA records it. This atlas does not explain what the type means.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "FDA product code of this record.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].openfda.device_class", "applicability_note": "Device class as the openFDA block writes it.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].openfda.regulation_number", "applicability_note": "The top-level regulation_number field is empty in this record. The openFDA block gives 870.1130.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "results[0].openfda.device_name", "applicability_note": "FDA's name for the device type, which is broader than one model.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "results[0].statement_or_summary", "applicability_note": "Shows the record is a Statement, which is why no indications text was found.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "meta.disclaimer", "applicability_note": "openFDA's own disclaimer about relying on its data.", "snapshot": { "id": "cardio:openfda-510k-k001848-2026-10-11", "retrieved_at": "2026-10-11T19:11:27Z", "content_hash": "e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883", "source_effective_date": "2026-09-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-510k-k001848", "source_type": "regulator", "title": "FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001848", "identifier_namespace": "fda-510k", "identifier_value": "K001848", "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) record returned on 2026-10-11, from a dataset last updated 2026-09-28. The record is a Statement, not a Summary. The FDA 510(k) database page for the same number was also fetched and gives the same number, applicant, product code, regulation number, clearance type and decision date. Only the openFDA JSON is kept as a snapshot.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-11, hash only). The raw record is committed at research/snapshots/ca-openfda-510k-k001848.json. It includes the 510(k) contact name that FDA publishes and long lists of establishment registration numbers for the product code. Records here do not repeat them.", "public_text": "quote" } } ], "review": { "content_digest": "db304d8b5e9f6b1a653c770003dd60a81f7dd23a381a0ee447e90578cc69d369", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-k001848-clearance.json" }, { "release_id": "2b2017b84496b985", "id": "cardio:claim-hem907-passed-international-protocol", "owner": "cardio", "subject_entity_id": "cardio:omron-hem-907", "category": "descriptive", "statement": "A 2002 paper in Blood Pressure Monitoring reports that the Omron HEM-907 passed both phases of the international validation protocol. The final phase used 33 people in all. Two trained observers took readings with mercury sphygmomanometers, alternating with the device, and 99 measurements were compared. In the second phase the average differences between the device and the mercury readings were -1 +/- 7 mmHg for systolic and -5 +/- 6 mmHg for diastolic pressure.", "context": { "id": "cardio:ctx-hem907-validation-2002", "label": "People measured in the 2002 validation study of the Omron HEM-907", "recipient": "unknown", "population": "33 people in the final phase of the validation, as the abstract counts them. The abstract does not describe who they were.", "care_setting": "Not stated in the abstract", "geography": "Not stated in the abstract", "life_stage": "Not stated in the abstract", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not stated in the abstract. The abstract describes two observers measuring at the same time, alternating with the device, and gives no follow-up period.", "eligibility": { "inclusion": [], "exclusion": [] } }, "evidence_stage": "observational", "certainty": "not_assessed", "certainty_method": null, "limitations": "Abstract only: the full text was not fetched. The abstract calls the test the international validation protocol and does not name who wrote it, so it is not called the ESH International Protocol here. A pass in 33 people measured in a study session is not accuracy in everyday use, at home or in a clinic. The abstract does not describe who the 33 people were. It tested the HEM-907 only, and the result does not carry over to the HEM-907XL or to any other model. The protocol itself was not read, so the pass criteria are not described here.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, sentence 2", "applicability_note": "PubMed abstract of the 2002 paper.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, sentence 3", "applicability_note": "PubMed abstract of the 2002 paper.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, sentence 4", "applicability_note": "PubMed abstract of the 2002 paper.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, sentence 8, opening words", "applicability_note": "PubMed abstract of the 2002 paper. Opening words of the second-phase sentence.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, sentence 8", "applicability_note": "PubMed abstract of the 2002 paper.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, last sentence", "applicability_note": "The authors' own conclusion in the abstract.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Article title", "applicability_note": "Names the device as the Omron HEM-907.", "snapshot": { "id": "cardio:pubmed-12198340-2026-10-11", "retrieved_at": "2026-10-11T19:11:59Z", "content_hash": "40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:hem907-validation-2002", "source_type": "publication", "title": "Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)", "canonical_url": "https://pubmed.ncbi.nlm.nih.gov/12198340/", "identifier_namespace": "pmid", "identifier_value": "12198340", "publication_date": null, "publisher": "Lippincott Williams & Wilkins (Blood Pressure Monitoring)", "edition": "Blood Pressure Monitoring, August 2002 issue. The PubMed record and its abstract only. The full text was not fetched.", "reuse_basis": "The abstract carries a publisher copyright line, so only short quotations with attribution are used and only the sha256 of the PubMed record is kept. No file is committed.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Device page for the Omron HEM-907", "applicability_note": "An outside group that keeps its own device lists has a page for this model. It is named and linked for identity only, and its content is not restated here.", "snapshot": { "id": "cardio:stridebp-device-hem907-2026-10-12", "retrieved_at": "2026-10-12T13:14:41Z", "content_hash": "a2dddb8f7d18b0d3a97a76e63ea46c0f22b048700fc884874949a3b742d517c7", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:stride-bp-site", "source_type": "webpage", "title": "STRIDE BP website: home, about us, principles for device listing, terms of use, BP Monitors list and one device page", "canonical_url": "https://www.stridebp.org/", "identifier_namespace": null, "identifier_value": null, "publication_date": null, "publisher": "STRIDE BP", "edition": "Six pages of the site read in the in-app Browser pane on 2026-10-12, one snapshot each: home, about us, principles for device listing, terms of use, the BP Monitors list and the Omron HEM-907 device page. The snapshot hash is the sha256 of the rendered page text as the browser showed it, not of the page's HTML. The home, about and principles pages carry no date. The terms page gives 15 January 2024 as its update date. The device page was reached by typing HEM-907 into the search box on the BP Monitors page and opening the result. The list snapshot is the unfiltered first page of the BP Monitors page, opened by its address. The terms, principles and list pages were each opened again on 2026-10-12 with identical hashes, and the log has a row for each of the three re-reads. An earlier scripted fetch of these pages on 2026-10-11 returned HTTP 403 and then HTTP 200 after the user agent was changed. Those scripted fetches are not used as evidence (see the research notes).", "reuse_basis": "All rights reserved, as the page footer states. The terms of use do not allow copying the service or incorporating its content into another site, do not allow searching it other than through its public interface (the site's own search box and device pages are read that way here), and do not allow circumventing its security measures. Nothing from the site is committed. Only sha256 hashes of the rendered text are kept. Public text is identity_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages give the name and a link only, and a claim that rests only on this site stays out of the public build.", "public_text": "identity_only" } } ], "review": { "content_digest": "ea4a6bfb61096518b98c91e45f417fc55df01d21db3e918ff84b6eced9f910a9", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-hem907-passed-international-protocol.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-k001848", "product_id": "cardio:omron-hem-907", "product_version": "HEM-907", "indication": "Not stated in the fetched FDA record", "context_id": "cardio:ctx-fda-k001848-us-clearance", "jurisdiction": "United States", "authority_id": "core:fda", "decision_type": "clearance", "submission_id": "K001848", "pathway": "510k", "product_code": "DXN", "device_class": "II", "decision_date": "2000-07-03", "valid_to": null, "claim_id": "cardio:claim-fda-k001848-clearance" } ], "relationships": { "outgoing": [ { "predicate": "related_to", "label": "FDA product code DXN", "clinical_claim_not_fact": false, "other_entity_id": "core:automated-upper-arm-cuff-device", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "related_to", "label": "Applicant named on the 2000 FDA clearance; the sources read do not say who makes the monitor", "clinical_claim_not_fact": false, "other_entity_id": "cardio:omron-healthcare", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "related_to", "label": "STRIDE BP has its own page for this model; its content is not restated here", "clinical_claim_not_fact": false, "other_entity_id": "cardio:stride-bp-validated-device-lists", "other_entity_in_atlas": true, "claim_id": null } ], "incoming": [] }, "page_path": "products/omron-hem-907/", "context_path": "api/v1/context/cardio--omron-hem-907.md" }