# FMT: Warmer, Infant Radiant

- Device class: 2; regulation: 21 CFR 880.5130; FDA's rule: 510(k) required
- FDA decisions: 92
- 510(k) review time 2021–2025: median 116 days (middle half 100–149)
- Recalls: 19 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 1
- 2012: 4
- 2013: 1
- 2018: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer (2000), cited by 6
- K940951: RW Resucitaire Infant Radiant Warmer (1995), cited by 5
- K002355: Atom Infa Warmer V-505 (2000), cited by 5
- K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso (1994), cited by 3
- K921766: Ohio Infant Warmer System (1993), cited by 3
- K070377: Giraffe and Panda Warmer (2007), cited by 3
- K963058: Infant Warmer System (1996), cited by 2
- K101804: Giraffe and Panda Warmers (2010), cited by 2
- K122267: Giraffe and Panda Warmers (2012), cited by 2
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) (2007), cited by 2

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