FDA product code QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
QME is the FDA product code for software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. It is a Class II device, regulated under 21 CFR 870.2785 and reviewed by the Cardiovascular panel. FDA has cleared 12 510(k) submissions under QME, 11 in the last five years, from 8 different applicants. The average 510(k) review took 187 days (median 190); 212 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
Classification
| Field | Value |
|---|---|
| Device name | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Device class | Class II |
| Regulation | 21 CFR 870.2785 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QME
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 29 |
| 2022 | 1 | 32 |
| 2023 | 1 | 270 |
| 2024 | 3 | 233 |
| 2025 | 2 | 204 |
| 2026 | 4 | 200 |
Compare with all 510(k) review times · Search every QME clearance
Top QME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxehealth Limited | 4 | 2026-02-02 |
| Mindset Medical, Inc. | 2 | 2025-05-30 |
| Presage Security, Inc. d/b/a Presage Technologies, Inc. | 1 | 2026-06-18 |
| Nuralogix Corporation | 1 | 2026-06-11 |
| PanopticAI Technologies Limited | 1 | 2026-05-21 |
3 more applicants have QME clearances. See the full list in Caduvo.
Most recent QME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254169 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | SmartSpectra Vital Signs Monitor 1.0 | 2026-06-18 | 177 |
| K253650 | Nuralogix Corporation | Anura Mobile Core SDK (M1) | 2026-06-11 | 203 |
| K260066 | PanopticAI Technologies Limited | PanopticAI Vital Signs (1.6.1-22) | 2026-05-21 | 132 |
| K251200 | Oxehealth Limited | Vital Signs | 2026-02-02 | 290 |
| K243687 | Oxehealth Limited | Vital Signs | 2025-08-27 | 271 |
Recalls for QME devices
openFDA lists no recalls for product code QME.
Frequently asked questions
What is FDA product code QME?
QME is the FDA product code for software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. It is a Class II device, regulated under 21 CFR 870.2785 and reviewed by the Cardiovascular panel.
What device class is QME?
Class II, regulation 21 CFR 870.2785. Typical premarket route: 510(k).
How long does a 510(k) take for product code QME?
Across 12 cleared submissions the average was 187 days from receipt to decision (median 190).
Which companies have the most QME clearances?
Oxehealth Limited (4); Mindset Medical, Inc. (2); Presage Security, Inc. d/b/a Presage Technologies, Inc. (1); Nuralogix Corporation (1); PanopticAI Technologies Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QME
- Run a recall and safety report across every QME manufacturer
- Watch product code QME for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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