# MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

- Device class: 2; regulation: 21 CFR 870.2300; FDA's rule: 510(k) required
- FDA decisions: 309
- 510(k) review time 2021–2025: median 227 days (middle half 147–269)
- Recalls: 52 (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: 13
- 2018: 11
- 2019: 14
- 2020: 8
- 2021: 9
- 2022: 5
- 2023: 8
- 2024: 10
- 2025: 4
- 2026: 6

## Most-cited predicates
- K012059: 8100/8500 Vital Signs Monitor (2001), cited by 6
- K053234: PM-9000 Express Patient Monitor (2006), cited by 6
- K033378: Vital Signs Monitor, Propaq LT (2004), cited by 6
- K032142: Datacaptor (2003), cited by 5
- K171121: Masimo Root Monitoring System and Accessories (2017), cited by 5
- K193242: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (2020), cited by 5
- K043348: Modification to PM-8000 Patient Monitor (2005), cited by 5
- K030419: Viterion 100 Telehealth Monitor (2003), cited by 5
- K001020: 8100 Vital Signs Monitor (2000), cited by 5
- K080173: STAR 55 (2008), cited by 4

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