De Novo · Granted
GrantedOxehealth Vital Signs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxehealth Limited · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Granted on Mar 26, 2021 as a new device type through De Novo after a 364-day review. 11 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 364 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
11 later devices descend from it, 1 citing it directly.
- This deviceDEN200019 Oxehealth Vital SignsOxehealth Limited · 2021
- Descendant · cites it directly · 10 of its ownK211906 Vital SignsOxehealth Limited · 2021
- Descendant · 2 generations on · 1 of its ownK240890 PanopticAI Vital SignsPanopticAI technologies Limited · 2024
- Descendant · 2 generations on · 1 of its ownK223622 FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. · 2023
- Descendant · 2 generations on · 0 of its ownK254169 SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K211906Vital SignsOxehealth Limited · 2021 · cites it directly10descendants
- K240890PanopticAI Vital SignsPanopticAI technologies Limited · 2024 · 2 generations on1descendant
- K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. · 2023 · 2 generations on1descendant
- K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc. · 2026 · 2 generations on0descendants
- K253650Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021 | — |
| +1 | K211906 | Vital Signs | Oxehealth Limited | 2021 | — |
| +2 | K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024 | — |
| +2 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023 | — |
| +2 | K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026 | — |
| +3 | K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QME? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QME device
- #1 K211906 Vital Signsscore 28.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211906 | Vital Signs | 2021 | 10 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211906 (Oxehealth Limited, 2021) has gone furthest, with 10 descendants of its own.
How does its category compare?
All QME devicesQME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QME
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QME
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QME
No recall names QME since 2007.
Adverse event reports per year · QME
No MAUDE report names QME since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 266 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 190 | 0 | — |
What is it indicated for?
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…
Read the full statement (140 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200019 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200019: Oxehealth Vital Signs.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026