# QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use

- Device class: 2; regulation: 21 CFR 870.2790; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 126 days (middle half 84–187)
- 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)
- 2018: 1
- 2021: 1
- 2022: 2
- 2023: 1

## Most-cited predicates
- DEN180042: Irregular Rhythm Notification Feature (2018), cited by 3
- K212516: IRNF App (2021), cited by 2
- K212372: Fitbit Irregular Rhythm Notifications (2022), cited by 1

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