510(k) · Cleared
ClearedVital 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
Cleared on Jul 20, 2021 as substantially equivalent to DEN200019 (Oxehealth Limited, 2021) after a 29-day review. Its family tree reaches back 1 generation to 2021. 10 later devices descend from it.
- Decided
- Jul 20, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200019 (2021). 10 later devices descend from it, 9 citing it directly.
- Root · 1 generation backDEN200019 Oxehealth Vital SignsOxehealth Limited · 2021
- This deviceK211906 Vital SignsOxehealth Limited · 2021
- Descendant · cites it directly · 1 of its ownK240890 PanopticAI Vital SignsPanopticAI technologies Limited · 2024
- Descendant · cites it directly · 1 of its ownK223622 FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. · 2023
- Descendant · cites it directly · 0 of its ownK254169 SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
- Descendant · cites it directly · 0 of its ownK260066 PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K240890PanopticAI Vital SignsPanopticAI technologies Limited · 2024 · cites it directly1descendant
- K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. · 2023 · cites it directly1descendant
- K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc. · 2026 · cites it directly0descendants
- K253650Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026 · 2 generations on0descendants
- K260066PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021 | — |
| 0 (this device) | K211906 | Vital Signs | Oxehealth Limited | 2021 | — |
| +1 | K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024 | — |
| +1 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023 | — |
| +1 | K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026 | — |
| +2 | K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026 | — |
| +1 | K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) 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 K253650 Anura Mobile Core SDK (M1)score 14.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200019 | Oxehealth Vital SignsSummary page 4…ical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. Predicate Devices: Oxehealth Vital Signs version 1.30.0 (classified in DEN200019) Purpose of the Special 510(k) Notice: The Oxehealth Vital Signs medical device is a modification to Oxehealth Vital Signs versi… | 2021 |
What descends from it? (10)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240890 | PanopticAI Vital Signs | 2024 | 1 |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | 2023 | 1 |
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | 2026 | 0 |
| K260066 | PanopticAI Vital Signs (1.6.1-22) | 2026 | 0 |
| K251200 | Vital Signs | 2026 | 0 |
| K243687 | Vital Signs | 2025 | 0 |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | 2025 | 0 |
| K241633 | Informed Vital Core Application (IVC App) | 2024 | 0 |
| K220899 | Oxehealth Vital Signs | 2022 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K240890 (PanopticAI technologies Limited, 2024) has gone furthest, with 1 descendant 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211906: Vital Signs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211906
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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