# QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

- Device class: 2; regulation: 21 CFR 870.2785; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 216 days (middle half 111–269)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 3
- 2025: 2
- 2026: 4

## Most-cited predicates
- K211906: Vital Signs (2021), cited by 9
- K232804: FibriCheck (2024), cited by 1
- K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK) (2023), cited by 1
- K240890: PanopticAI Vital Signs (2024), cited by 1
- DEN200019: Oxehealth Vital Signs (2021), cited by 1

Source page: https://510kreport.com/product-code/QME
Data by year (CSV): https://510kreport.com/product-code/QME.csv