# FPL: Incubator, Neonatal Transport

- Device class: 2; regulation: 21 CFR 880.5410; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 123 days (middle half 123–123)
- 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)
- 2000: 1
- 2002: 1
- 2003: 2
- 2006: 2
- 2008: 1
- 2011: 4
- 2013: 1
- 2014: 1
- 2017: 1
- 2022: 1

## Most-cited predicates
- K941106: Model TI500 Isolette Infant Incubator (1994), cited by 3
- K031096: Modification to Transport Incubator 185 (2003), cited by 3
- K001019: TI500 Globe-Trotter Transport System (2000), cited by 3
- K850496: Transport Incubator 185 (1985), cited by 2
- K033565: LMT Nomag IC 1,5 (2003), cited by 2
- K081399: Aviator Transport Incubator (2008), cited by 1
- K022876: Modification to Infant Life Support Module-20 (2002), cited by 1
- K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox (2011), cited by 1
- K062052: LMT Nomag IC 3.0 (2006), cited by 1
- K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox (2011), cited by 1

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