# FMZ: Incubator, Neonatal

- Device class: 2; regulation: 21 CFR 880.5400; FDA's rule: 510(k) required
- FDA decisions: 86
- 510(k) review time 2021–2025: median 145 days (middle half 130–214)
- Recalls: 30 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 2
- 2022: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K001242: Isolette Infant Incubator, Model C2HS (2000), cited by 7
- K993407: Ohmeda Medical Omnibed (2000), cited by 6
- K960980: Isolette Infant Incubator (1996), cited by 4
- K010222: Ohmeda Medical Giraffe Incubator (2001), cited by 3
- K061856: V-2200 Infant Incubator (2006), cited by 3
- K162821: Babyleo TN500 (2017), cited by 2
- K974349: Ohmeda-Ohio Care Plus Incubator (1998), cited by 2
- K071175: Ohmeda Medical Giraffe Omnibed (2007), cited by 2
- K021809: V-2100G Advanced Infant Incubator (2002), cited by 2
- K954204: Drager Incubator 8000 IC (1997), cited by 2

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