# DQA: Oximeter

- Device class: 2; regulation: 21 CFR 870.2700; FDA's rule: 510(k) required
- FDA decisions: 727
- 510(k) review time 2021–2025: median 261 days (middle half 178–343)
- Recalls: 98 (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)
- 2017: 9
- 2018: 18
- 2019: 19
- 2020: 15
- 2021: 10
- 2022: 20
- 2023: 13
- 2024: 14
- 2025: 15
- 2026: 8

## Most-cited predicates
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), cited by 34
- K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B (2002), cited by 31
- K991823: N-395 Pulse Oximeter, Model N-395 (1999), cited by 21
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables (2003), cited by 14
- K863784: Nellcor N-200 (Pulse Oximeter) (1986), cited by 14
- K993637: N-395 Pulse Oximeter, with Extended Device Claims (1999), cited by 12
- K051212: Modification to LNCS Oximetry Sensors (2005), cited by 12
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter (2002), cited by 11
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter (2008), cited by 11
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V (2004), cited by 11

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