# LHC: Warmer, Irrigation Solution

- Device class: 1; regulation: 21 CFR 890.5950; FDA's rule: 510(k) exempt
- FDA decisions: 24
- Recalls: 8 (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)
- 1997: 1
- 1998: 1
- 2000: 1
- 2002: 4
- 2005: 1
- 2008: 1
- 2009: 1
- 2014: 2
- 2015: 1
- 2016: 2

## Most-cited predicates
- K021288: ORS-1000LD (2002), cited by 3
- K023282: ORS-3000LD (2002), cited by 2
- K933726: Modification of Bair Hugger Patient Warming System (1994), cited by 1

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