510(k) · Cleared
ClearedFaceHeart Vitals Software Development Kit (FH vitals SDK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Faceheart Corp. · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cleared on Sep 1, 2023 as substantially equivalent to K211906 (Oxehealth Limited, 2021) after a 270-day review. Its family tree reaches back 2 generations to 2021. 1 later device descends from it.
- Decided
- Sep 1, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200019 (2021). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN200019 Oxehealth Vital SignsOxehealth Limited · 2021
- 1 generation backK211906 Vital SignsOxehealth Limited · 2021
- This deviceK223622 FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. · 2023
- Descendant · cites it directly · 0 of its ownK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K253650Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021 | — |
| −1 | K211906 | Vital Signs | Oxehealth Limited | 2021 | — |
| 0 (this device) | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023 | — |
| +1 | K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 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
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 |
|---|---|---|---|
| * | K211906 | Vital SignsSummary page 5…Page 1 of 10 Predicate Trade Oxehealth Vital Signs Name Predicate 510 (k) K211906 3. Device Description: FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recogn… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253650 | Anura Mobile Core SDK (M1) | 2026 | 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253650 (Nuralogix Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K211906.
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. 2023, 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 FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias. While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not…
Read the full statement (150 words)
The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.
While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.
The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223622
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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