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Omron HEM-907 blood pressure monitor

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.

Also called HEM-907 · Omron IntelliSense blood pressure monitor, model HEM-907

  • Product
  • In this atlas

Overview

Technical summary

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.

Product details

Type
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 sources

No intended-use source is recorded.

Claims and evidence

Context People measured in the 2002 validation study of the Omron HEM-907

Recipient
Recipient not specified
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
Not reported
Postnatal age
Not reported
Follow-up
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 criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Description Observational Certainty not assessed

    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.

    Applies to Recipient not specified
    • 33 people in the final phase of the validation, as the abstract counts them. The abstract does not describe who they were.
    • Not stated in the abstract
    • Not stated in the abstract
    • Not stated in the abstract
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up 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.
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-11
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, sentence 2
      How it applies
      PubMed abstract of the 2002 paper.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    2. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, sentence 3
      How it applies
      PubMed abstract of the 2002 paper.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    3. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, sentence 4
      How it applies
      PubMed abstract of the 2002 paper.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    4. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, sentence 8, opening words
      How it applies
      PubMed abstract of the 2002 paper. Opening words of the second-phase sentence.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    5. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, sentence 8
      How it applies
      PubMed abstract of the 2002 paper.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    6. Supports Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Abstract, last sentence
      How it applies
      The authors' own conclusion in the abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    7. Background Validation of the Omron HEM-907 device for blood pressure measurement (El Assaad and colleagues, Blood Pressure Monitoring)

      Publication · 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. · pmid: 12198340

      Locator
      Article title
      How it applies
      Names the device as the Omron HEM-907.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40b158f63ee3426124368d60b54951c88e37882f5b9b1556040d8b7484d893ae
      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.

    8. Background STRIDE BP website: home, about us, principles for device listing, terms of use, BP Monitors list and one device page

      Webpage · 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).

      Locator
      Device page for the Omron HEM-907
      How it applies
      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.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a2dddb8f7d18b0d3a97a76e63ea46c0f22b048700fc884874949a3b742d517c7
      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.

Context United States 510(k) clearance record K001848 for the Omron HEM-907

Recipient
Recipient not specified
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
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Recipient not specified
    • Not stated in the FDA record. The record names a device and an applicant, and gives no intended population.
    • Not stated in the FDA record
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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".
    Last checked
    2026-10-11
    Next evidence check due
    Not scheduled
    Sources and citations (12)

    1. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].k_number
      How it applies
      The 510(k) number of this record.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    2. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].device_name
      How it applies
      Names the model as HEM-907.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    3. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    4. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].decision_date
      How it applies
      ISO date. The FDA database page writes the same date as a month-first slash date.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    5. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].decision_description
      How it applies
      The decision wording used for a 510(k) clearance.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    6. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].clearance_type
      How it applies
      The clearance type as FDA records it. This atlas does not explain what the type means.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    7. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    8. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].openfda.device_class
      How it applies
      Device class as the openFDA block writes it.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    9. Supports FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].openfda.regulation_number
      How it applies
      The top-level regulation_number field is empty in this record. The openFDA block gives 870.1130.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    10. Background FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].openfda.device_name
      How it applies
      FDA's name for the device type, which is broader than one model.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    11. Background FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      results[0].statement_or_summary
      How it applies
      Shows the record is a Statement, which is why no indications text was found.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

    12. Background FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)

      Regulator · 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. · fda-510k: K001848

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-09-28
      Source state
      Current
      Snapshot hash
      e9ec84a5a0971709c2a99a407c916e5d9148b736bc816b51e9c4b14a25b25883
      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.

Authorization

Regulatory decision: Omron HEM-907 blood pressure monitor

Applies to Recipient not specified
  • Not stated in the FDA record. The record names a device and an applicant, and gives no intended population.
  • Not stated in the FDA record
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K001848
Product code
DXN
Device class
Class II
Jurisdiction
United States
Product version
HEM-907
Indication
Not stated in the fetched FDA record
Basis
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.

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".

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:omron-hem-907
Content hash
7f1c5432cbcce8a1fccbc160197c6c1a2950b6c367a901f5722d5f6d80bab8df