# IMD: Pack, Hot Or Cold, Disposable

- Device class: 1; regulation: 21 CFR 890.5710; FDA's rule: 510(k) exempt
- FDA decisions: 82
- 510(k) review time 2021–2025: median 121 days (middle half 121–121)
- 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)
- 1996: 9
- 1997: 3
- 1998: 1
- 1999: 1
- 2002: 1
- 2007: 1
- 2008: 1
- 2012: 1
- 2017: 1
- 2022: 1

## Most-cited predicates
- K951033: Andela Dynamic Cooling Device (1996), cited by 5
- K936084: Omni Warm Gel Packs (1994), cited by 2
- K950680: Infant Heel Warmer (1995), cited by 2
- K970399: Kwik Kold Peri Cold Pack (Catalog Number TBD) (1997), cited by 2
- K912715: Instant Warm Gel Pack (1991), cited by 2
- K890553: CP&S Disposable Instant Cold Compress (1989), cited by 1
- K963666: Instant Cold Pack (1996), cited by 1
- K112547: Neo Nest (2012), cited by 1
- K982652: Allegiance Porta-Warm Mattress (1999), cited by 1
- K953442: Restore, Thermacells  (Hot Pack I) (1995), cited by 1

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