QME
13 FDA 510(k) clearances · Product code
203 daysmedian time to decision
290 days90th percentile
13clearances measured
FDA profile
- Official device name
- Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2785
- Medical specialty
- Cardiovascular
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SmartSpectra Vital Signs Monitor 1.0 (K254169) | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026-06-18 |
| Anura Mobile Core SDK (M1) (K253650) | Nuralogix Corporation | 2026-06-11 |
| PanopticAI Vital Signs (1.6.1-22) (K260066) | PanopticAI Technologies Limited | 2026-05-21 |
| Vital Signs (K251200) | Oxehealth Limited | 2026-02-02 |
| Vital Signs (K243687) | Oxehealth Limited | 2025-08-27 |
| Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (K250078) | Mindset Medical, Inc. | 2025-05-30 |
| PanopticAI Vital Signs (K240890) | PanopticAI technologies Limited | 2024-12-23 |
| Informed Vital Core Application (IVC App) (K241633) | Mindset Medical, Inc. | 2024-11-18 |
| FibriCheck (K232804) | Qompium NV | 2024-06-07 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK) (K223622) | Faceheart Corp. | 2023-09-01 |
| Oxehealth Vital Signs (K220899) | Oxehealth Limited | 2022-04-29 |
| Vital Signs (K211906) | Oxehealth Limited | 2021-07-20 |
| Oxehealth Vital Signs (DEN200019) | Oxehealth Limited | 2021-03-26 |
Track QME automatically
Every clearance here is in the API, with alerts when new ones post.