Cardiovascular · 510(k) · 2025
Vital Signs
Oxehealth Limited. Cleared by FDA on 27 August 2025 under submission K243687, product code QME (software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate). What FDA's record says, in FDA's words.
Device record · K243687
- Device. Vital SignsDEVICE
- Company. Oxehealth Limited (GB)COMPANY
- Decision. 27 August 2025, 510(k), substantially equivalent (traditional review); received 29 November 2024DECISION
- Panel. CardiovascularPANEL
- Product code. QME, Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory RateCODE
- Regulation. 21 CFR 870.2785, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This K243687 ? textbox will be left blank for original applications/submissions. 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 � Prescription Use (Part 21 CFR 801 Subpart D) applicable). D Over-The-Counter Use (21 CFR 801 Subpart C) ? Vital Signs 510(k) Summary Vital Signs - K243687 22 August 2025 1/6 510(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 […]
The product code's definition, from FDA's classification record. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QME. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QME, in Cardiovascular, from Oxehealth Limited, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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