# QOK: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

- Device class: 2; regulation: 21 CFR 870.2786; FDA's rule: 510(k) required
- FDA decisions: 2
- 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: 1
- 2026: 1

## Most-cited predicates
- DEN200038: Gili Pro BioSensor (also known as “Gili BioSensor System”) (2021), cited by 1

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