Vital Signs
K243687 · Oxehealth Limited · QME · Aug 27, 2025 · Cardiovascular
Device Facts
| Record ID | K243687 |
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| Device Name | Vital Signs |
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| Applicant | Oxehealth Limited |
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| Product Code | QME · Cardiovascular |
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| Decision Date | Aug 27, 2025 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.2785 |
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| Device Class | Class 2 |
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| Attributes | AI/ML, Software as a Medical Device |
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Intended Use
The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety. The system is intended for use by appropriately trained staff and should not be used by untrained users. The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject.
Device Story
Vital Signs is a software-only medical device (SaMD) providing non-contact, retrospective monitoring of pulse and respiratory rates. It processes video footage from fixed, off-the-shelf cameras installed in single-occupancy rooms. Using proprietary machine learning algorithms, the software analyzes video data to derive physiological measurements when the subject is still. The system is operated by trained healthcare staff to support periodic safety checks. Output includes spot measurements and 24-hour trends, exported as electronic reports (PDF). The device aids clinical decision-making by providing objective vital sign data without requiring patient-worn sensors, benefiting patients in secured or general care environments by reducing the need for physical contact during monitoring.
Clinical Evidence
Clinical validation study with 30 subjects across the intended population (including adolescents 12-17 and adults). Subjects performed real-world activities under varied environmental conditions. Performance was compared against gold-standard references: FDA-cleared finger pulse oximeter for heart rate and physician-annotated capnogram for respiratory rate. Results showed heart rate MAE < 3 bpm and respiratory rate MAE < 2 breaths/min (p <= 0.05). Accuracy was maintained across age, sex, Fitzpatrick skin tone, and BMI subgroups, validating the extended age range and respiratory rate range.
Technological Characteristics
SaMD using off-the-shelf cameras and computers. Connectivity via structured network cabling. Software-based machine learning algorithm for physiological signal extraction from video. Standards applied: ISO 14971:2019, AAMI BS 34971:2022 (AI/ML risk), IEC 62304:2006 (software lifecycle), IEC 82304-1, IEC 80001-1, IEC 81001-5-1 (cybersecurity), IEC 62366-1 (usability).
Indications for Use
Indicated for noninvasive spot measurement of pulse rate and breathing rate in subjects 12 years of age or older in single-occupancy hospital, general care, or secured environments. Not for critical care or continuous monitoring. Requires professional healthcare oversight.
Regulatory Classification
Identification
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.
Special Controls
In combination with the general controls of the FD&C Act, the software for optical camerabased measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements;
(iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and
(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
(2) Clinical data must be provided. This assessment must fulfill the following:
(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.
(4) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) The expected performance of the device for all intended use populations and environments; and
(v) Robust instructions to ensure correct system setup.
Predicate Devices
Related Devices
- K251200 — Vital Signs · Oxehealth Limited · Feb 2, 2026
- K211906 — Vital Signs · Oxehealth Limited · Jul 20, 2021
- K220899 — Oxehealth Vital Signs · Oxehealth Limited · Apr 29, 2022
- DEN200019 — Oxehealth Vital Signs · Oxehealth Limited · Mar 26, 2021
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
August 27, 2025
Oxehealth Limited
John Kemeny
Head of Compliance
Bee House, 140 Eastern Ave
Milton Park
Abingdon, OX14 4SB
United Kingdom
Re: K243687
Trade/Device Name: Vital Signs
Regulation Number: 21 CFR 870.2785
Regulation Name: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Regulatory Class: Class II
Product Code: QME
Dated: July 23, 2025
Received: July 28, 2025
Dear John Kemeny:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K243687 - John Kemeny
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K243687 - John Kemeny
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JENNIFER W. SHIH -S
Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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Vital Signs
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K243687 | ? |
| Please provide the device trade name(s). | | ? |
| Vital Signs | | |
| Please provide your Indications for Use below. | | ? |
| The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when
the subject is still. It is software assessing video footage from a fixed-installation solution for use within
single occupancy rooms within hospitals, general care and secured environments with professional
healthcare oversight and where a framework exists which mandates periodic checks by a trained
professional to ensure subject safety.
The system is intended for use by appropriately trained staff and should not be used by untrained users.
The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical
care or continuous vital signs monitoring.
The device is not intended to be the sole method of checking the physical health of a subject. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
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510(k) Summary
Vital Signs - K243687
# oxehealth®
# 510(k) Summary
Vital Signs
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
## General information
Submitter's Name: John Kemeny
Address: Oxehealth Limited
Bee House
140 Eastern Avenue, Milton Park
Oxfordshire
OX14 4SB, UK
Phone: +44 (0) 1865 900 599
Contact Person: John Kemeny
Email: john.kemeny@oxehealth.com
Date Prepared: 22 August 2025
## Device Information
Trade name: Vital Signs
Common Name: Vital Signs
Address of Sponsor: Oxehealth Limited
Bee House
140 Eastern Avenue, Milton Park
Oxfordshire
OX14 4SB, UK
Classification Name: QME, Biofeedback device, 21 CFR 870.2785
Predicate Device: Vital Signs - K211906
22 August 2025
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510(k) Summary
Vital Signs - K243687
## Indication for Use:
The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care, and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.
The system is intended for use by appropriately trained staff and should not be used by untrained users.
The Vital Signs device is indicated for use on subjects 12 years of age or older, who do not require critical care or continuous vital signs monitoring.
The device is not intended to be the sole method of checking the physical health of a subject.
## Device Description:
The subject device is the next generation device of the predicate (K211906). Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate data derived from video, without the need for contact devices to be attached to the patient or bed.
The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system’s data analysis.
Improvements to the device compared to the predicate are as follows:
- 24 hour trends
- Expansion of intended population from 18 years and older → 12 years and older
- Widened respiratory rate range from 8-31 bpm → 8-39 bpm
## Technological Characteristics and Comparison:
The subject device algorithm is identical to the predicate device. It uses the same methods of Vital sign detection and the same Machine Learning techniques as the predicate device (K211906). It also uses the same processing, pipeline, storage, management and display/interface components, and image processing as the predicate device. The subject device is substantially equivalent to the Vital signs device (K211906).
## Non Clinical Performance
Since the device is SaMD using off-the-shelf image acquisition and data processing equipment, no EMC or electrical safety testing has been performed.
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510(k) Summary
Vital Signs - K243687
Since the device has no patient contacting parts, no biocompatibility or mechanical safety testing has been performed.
Oxehealth have reviewed the FDA's database of recognized consensus standards and has consequently applied the following standards to the development of the device:
- ISO 14971:2019 + A11:2021 - Application of risk management to medical devices
- AAMI BS 34971:2022 - Application of risk management to Artificial Intelligence and Machine Learning Devices
- IEC 62304:2006 + A1:2015 - Software life cycle processes
- IEC 82304-1:2016 - Health software
- IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
- IEC 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
- IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC 62366-1:2015 +A1:2020 - Application of risk management to medical devices
- ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer
- ISO 20417:2021 Symbols to be used with information to be supplied by the manufacturer
The firm has also performed penetration and vulnerability testing in line with FDA's guidance on cybersecurity.
Substantial equivalence
| | Subject device | Predicate | Equivalence |
| --- | --- | --- | --- |
| Trade Name | Vital Signs | Vital Signs | |
| Submission reference | K243687 | K211906 | |
| Sponsor | Oxehealth Limited | Oxehealth Limited | Identical |
| Intended Use | Vital Sign monitoring | Vital Sign monitoring | Identical |
| Primary Product Code | QME | QME | Identical |
| Primary Regulation | 21 CFR 870.2785 | 21 CFR 870.2785 | Identical |
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510(k) Summary
Vital Signs - K243687
| Intended Use | The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.
The system is intended for use by appropriately trained staff, and should not be used by untrained users.
The device is not intended to be the sole method of checking the physical health of a subject. | The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.
The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.
The device is not intended to be the sole method of checking the physical health of a subject. | Substantially equivalent to the predicate device |
| --- | --- | --- | --- |
| Intended use population | Subjects 12 years of age or older. | Adults 18 years of age and over. | Substantially equivalent; no new questions of safety and effectiveness based on clinical validation testing in the intended population |
| Intended use environment | Single occupancy rooms within hospitals, general care and secured environments. | Single occupancy rooms within hospitals, general care and secured environments. | Identical |
| Patient Worn Device | No | No | Identical |
| Device outputs | Spot measurement of heart rate and respiratory rate | Spot measurement of heart rate and breathing rate (chest wall movements) | Substantially equivalent; respiratory rate output validated against gold standard |
| Reporting | User operates User Interface to view and/or export reports of vital sign trends in electronic form (.PDF). | None | Substantially equivalent |
| Design/Principle of operation | SaMD device using OTS hardware.
Measures movement, and physiological sign data using an optical sensor (camera - contactless). | SaMD device using OTS hardware.
Measures movement, and physiological sign data using an optical sensor (camera - contactless). | Identical |
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510(k) Summary
Vital Signs - K243687
| Clinical Validation | Accuracy Pulse rate measurement 50 to 130 ± 3 beats per minute Respiratory rate measurement 8 to 39 ± 2 breaths per minute | Accuracy Pulse rate measurement 50 to 130 ± 3 beats per minute Breathing rate measurement 8 to 31 ± 2 breaths per minute | Substantially equivalent; widened respiratory rate range was clinically validated against the gold standard in the intended population. |
| --- | --- | --- | --- |
| Commercial distribution | Prescription use. | Prescription use. | Identical |
| Technological Characteristics | | | |
| Software Components | The Vital Signs Device is installed in standard, off-the-shelf computers to retrieve collected data from the off-the-shelf video and generate reports based on collected data. | The Vital Signs Device is installed in standard, off-the-shelf computers to retrieve collected data from the off-the-shelf video and generate reports based on collected data. | Substantially Equivalent. Subject device Vital Signs Trends not available in the predicate device. No new questions of safety and effectiveness. |
| Hardware components | The Vital Signs Device is a software-only medical device (SaMD) supported by off-the-shelf hardware. | The Vital Signs Device is a software-only medical device (SaMD) supported by off-the-shelf hardware. | Identical |
| Data Collection method | Data collection is from an off-the shelf video camera, collecting continuously. | Data collection is from an off-the shelf video camera, collecting continuously. | Identical |
| Recording Time | 24 hours | N/A | The Vital sign trends feature has a record time of 24 hours |
| Data Recording Unit to PC Interface | The software is connected directly to the camera over structured network cabling | The software is connected directly to the camera over structured network cabling | Identical |
| User Interface | Application developed by the manufacturer, installed on OTS computer or mobile device. Installed by the manufacturer with no other applications in the operating environment. | Application developed by the manufacturer, installed on OTS computer or mobile device. Installed by Oxehealth with no other applications in the operating environment. | Identical |
Table 1: Summary substantial equivalence summary between the subject device and the predicate
# Clinical Performance
30 subjects representative of the intended population were dually monitored with both the subject device and reference devices for pulse rate and respiratory rate validation (FDA-cleared finger pulse oximeter and
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510(k) Summary
Vital Signs - K243687
capnogram respectively). Subjects performed a variety of activities reflecting real-world behavior, under a variety of environmental conditions similar to those expected in the intended environment. The subjects validated the entire claimed RR range using metronome breathing.
The capnogram output was manually-annotated by a physician blinded to both device outputs, which is the accepted gold standard for respiratory rate validation.
The study results demonstrated acceptable accuracy in all subgroups based on age, sex, Fitzpatrick skin tone, and BMI.
- The heart rate MAE is found to be significantly (P-value <= 0.05) less than three beats per minute;
- The respiratory rate MAE is found to be significantly (P-value <= 0.05) less than two breaths per minute.
All of the different subgroups were within the stated performance metrics of the device ( $\pm 2$ breaths per minute or $\pm 3$ beats per minute) for both the MAD and $95\%$ CI. Therefore, the performance of the subject device is substantially equivalent to the predicate and meets the stated performance of the subject device over the extended age range and measurement ranges.
All performance endpoints have been met, which substantiate the claim of substantial equivalence to the predicate device.
## Conclusions
The new data presented here demonstrate that the Vital Signs device is accurate against its designed accuracy targets ( $\pm 3$ bpm for pulse rate and $\pm 2$ breaths/min for respiratory rate) against gold standard reference data, under realistic conditions, for:
- Adolescents (ages 12-17) performing realistic activities;
- Adults performing realistic activities;
- Adolescents and adults exhibiting elevated respiratory rates up to 39 breaths/min.
Based on the comparison to the predicate devices and performance characteristics, the subject Vital Signs device is substantially equivalent to the currently U.S. legally marketed device Oxehealth Vital Signs predicate (K211906).
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