510(k) · Cleared
ClearedPanopticAI Vital Signs (1.6.1-22)
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 May 21, 2026 as substantially equivalent to K240890 (PanopticAI technologies Limited, 2024) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- May 21, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN200019 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200019 Oxehealth Vital SignsOxehealth Limited · 2021
- 2 generations backK211906 Vital SignsOxehealth Limited · 2021
- 1 generation backK240890 PanopticAI Vital SignsPanopticAI technologies Limited · 2024
- This deviceK260066 PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 |
|---|---|---|---|
| * | K240890 | PanopticAI Vital SignsSummary page 7…2 of 9 PanopticAI Vital Signs K260066 510(K) SUMMARY 4. Identification of Predicate Device K240890 PanopticAI Vital Signs and K211906 Oxehealth Vital Signs 5. Indications for Use The PanopticAI Vital Signs device is inte… | 2024 |
| * | K211906 | Vital SignsSummary page 7…ital Signs K260066 510(K) SUMMARY 4. Identification of Predicate Device K240890 PanopticAI Vital Signs and K211906 Oxehealth Vital Signs 5. Indications for Use The PanopticAI Vital Signs device is intended for non-invasive spot measurem… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
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. 2026, 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 PanopticAI Vital Signs device is intended for non-invasive spot measurement of pulse rate and respiratory rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera. The PanopticAI Vital Signs device is intended for use by healthcare professionals. The PanopticAI Vital Signs device is indicated for use on adults 18 to 60 years old who do not require critical care or…
Read the full statement (130 words)
The PanopticAI Vital Signs device is intended for non-invasive spot measurement of pulse rate and respiratory rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.
The PanopticAI Vital Signs device is intended for use by healthcare professionals.
The PanopticAI Vital Signs device is indicated for use on adults 18 to 60 years old who do not require critical care or continuous vital signs monitoring.
The PanopticAI Vital Signs device is not intended for continuous monitoring, apnea detection, or to independently direct therapy. It is not intended to be the sole method to assess a subject's physical health condition. The pulse rate and respiratory rate measurements it provides should complement, not replace, professional medical care and/or prescribed therapy.
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/K260066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260066: PanopticAI Vital Signs (1.6.1-22).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260066
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026