FDA De Novo · Oxehealth
DEN200019: Oxehealth Vital Signs (Oxehealth Limited)
Oxehealth Limited received FDA De Novo DEN200019 for Oxehealth Vital Signs, with a decision date of Mar 26, 2021.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN200019 |
|---|---|
| Pathway | De Novo |
| Applicant | Oxehealth Limited |
| Device name | Oxehealth Vital Signs |
| Product code | QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Regulation (21 CFR) | 870.2785 |
| Device class | Class 2 |
| Date received | Mar 27, 2020 |
| Decision date | Mar 26, 2021 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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 Oxehealth Vital Signs device is indicated for use on humans 18 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.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions.
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2785). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QME is "Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate", class 2, 21 CFR 870.2785. FDA's definition: "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."
Our labels for filtering: claim Heart rate / pulse, sensor Camera (rPPG). These are heuristics, not FDA fields.