# ILO: Pack, Hot Or Cold, Water Circulating

- Device class: 2; regulation: 21 CFR 890.5720; FDA's rule: 510(k) exempt
- FDA decisions: 93
- 510(k) review time 2021–2025: median 259 days (middle half 259–259)
- Recalls: 20 (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)
- 1993: 4
- 1994: 8
- 1995: 14
- 1996: 12
- 1997: 7
- 2004: 1
- 2007: 2
- 2008: 1
- 2009: 1
- 2022: 1

## Most-cited predicates
- K915196: Incare Hot/Ice System 3 (1992), cited by 2
- K964799: Artrotherm Cryotherapy and Thernotherapy (1997), cited by 2
- K931843: Hot/Ice System Sterile Conformable/Disp. Blankets (1994), cited by 2
- K760804: T-Pump, Temperature - Therapy Pump (1976), cited by 1
- K914434: Polar Pads (1991), cited by 1
- K830757: Hot/Ice (1983), cited by 1
- K833564: Hot/Ice Disposable Blanket (1983), cited by 1
- K970197: HTP-1500 Localized Heat Therapy Pump (1997), cited by 1
- K843146: Micro-Temp Pumps & Micro-Temp Pads (1984), cited by 1
- K945467: Babytherm 8000 WB (1995), cited by 1

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