# K905629: Pedicraft Infant Reflux Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Pedicraft, Inc.
- Decided: Mar 13, 1991 after 89 days
- Product code: FRP (Holder, Infant Position)
- Device class: 1
- Regulation: 21 CFR 880.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041996: Nightform (2004), 3 descendants of its own
- K090284: Res-Q Infant Wedge and Sling (2009), 1 descendant of its own
- K062143: Kozy Comfort Infant Positioner (2006), 1 descendant of its own
- K051300: Robin Hood Vest (2005), 1 descendant of its own
- K172962: Nurture Rest (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K905629
Methodology: https://510kreport.com/methodology