# LGZ: Warmer, Thermal, Infusion Fluid

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 76
- 510(k) review time 2021–2025: median 322 days (middle half 164–631)
- Recalls: 13 (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)
- 2015: 2
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 3
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K112902: Enflow IV Fluid Warmer (2012), cited by 5
- K092823: Amsco Warming Cabinet (2009), cited by 4
- K070654: Hyperthermia Pump (2007), cited by 4
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600, (2008), cited by 4
- K002409: Maxone, Blood, Blood Products and IV Fluid Warmer (2001), cited by 3
- K024373: Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 (2003), cited by 2
- K032674: Belmont Fluid Management System, Model FMS2000 (2003), cited by 2
- K911383: Hotline Fluid Warmer (1991), cited by 2
- K012276: TEMP 3 (2001), cited by 2
- K060939: Ranger Irrigation Fluid Warming System (2006), cited by 2

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