# DEN200019: Oxehealth Vital Signs

- Pathway: De Novo (Direct)
- Applicant: Oxehealth Limited
- Decided: Mar 26, 2021 after 364 days
- Product code: QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate)
- Device class: 2
- Regulation: 21 CFR 870.2785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211906: Vital Signs (2021), 10 descendants of its own
- K240890: PanopticAI Vital Signs (2024), 1 descendant of its own
- K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK) (2023), 1 descendant of its own
- K254169: SmartSpectra Vital Signs Monitor 1.0 (2026), 0 descendants of its own
- K253650: Anura Mobile Core SDK (M1) (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN200019
Methodology: https://510kreport.com/methodology