510(k) · Cleared
ClearedPanopticAI Vital Signs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PanopticAI technologies Limited · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cleared on Dec 23, 2024 as substantially equivalent to K211906 (Oxehealth Limited, 2021) after a 266-day review. Its family tree reaches back 2 generations to 2021. 1 later device descends from it.
- Decided
- Dec 23, 2024
- Review
- 266 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 deviceK240890 PanopticAI Vital SignsPanopticAI technologies Limited · 2024
- Descendant · cites it directly · 0 of its ownK260066 PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021 | — |
| −1 | K211906 | Vital Signs | Oxehealth Limited | 2021 | — |
| 0 (this device) | K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024 | — |
| +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 |
|---|---|---|
| 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 6…respiratory rate 3.4. Regulation Number: 21 CFR 870.2785 3.5. Device Class: Class II 3.6. Product Code: QME 4. Identification of Predicate Device K211906 Oxehealth Vital Signs Page 2 of 9… | 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 |
|---|---|---|---|
| K260066 | PanopticAI Vital Signs (1.6.1-22) | 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 3 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K260066 (PanopticAI Technologies Limited, 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. 2024, 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 PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera. The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects. The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who…
Read the full statement (119 words)
The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when
the subject is still. It is software for assessing facial video stream captured from a specified
smartphone or tablet camera.
The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only
intended to be used in healthy subjects.
The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not
require critical care or continuous monitoring.
The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's
physical health condition. The pulse rate measurements it provides should complement, not replace,
professional medical care and/or medication.
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/K240890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240890: PanopticAI Vital Signs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240890
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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