# FRP: Holder, Infant Position

- Device class: 1; regulation: 21 CFR 880.5680; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 0 (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)
- 1985: 1
- 1989: 1
- 1991: 2
- 1994: 1
- 1995: 1
- 2001: 1
- 2004: 1
- 2005: 1
- 2006: 2
- 2009: 2

## Most-cited predicates
- K041996: Nightform (2004), cited by 3
- K905629: Pedicraft Infant Reflux Wedge (1991), cited by 3
- K060986: Head Bed (2006), cited by 1
- K090284: Res-Q Infant Wedge and Sling (2009), cited by 1
- K932636: The Tucker Sling (1994), cited by 1
- K051300: Robin Hood Vest (2005), cited by 1
- K062143: Kozy Comfort Infant Positioner (2006), cited by 1

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