# MPO: Infant Heel Warmer (Chemical Heat Pack)

- Device class: 1; regulation: 21 CFR 890.5710; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 169 days (middle half 169–169)
- Recalls: 1 (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: 2
- 1997: 1
- 2003: 1
- 2004: 2
- 2006: 1
- 2011: 1
- 2015: 1
- 2016: 1
- 2022: 1

## Most-cited predicates
- K954716: Deroyal Industries Infant Heel Warmer (1996), cited by 2
- K032989: Medi-Heat Infant Heel Warmer (2003), cited by 1
- K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (2016), cited by 1
- K961154: Baxter Sodium Acetate Infant Heel Warmer (1996), cited by 1
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer (2015), cited by 1
- K040856: Rapid Aid Instant Disposable Infant Heel Warmer (2004), cited by 1

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