# K062143: Kozy Comfort Infant Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Alfred E Mann Inst. For Biomedical Engineering
- Decided: Oct 24, 2006 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
Longest line of descent: 2 generations back to K905629 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041996: Nightform, Plastic Surgery Solutions, LLC (2004) Summary page 1.
- K905629: Pedicraft Infant Reflux Wedge, Pedicraft, Inc. (1991) Summary page 1.

## Most influential descendants
- K082367: Infant Sleep Beanie (2009), 0 descendants of its own

## Indications for use
The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly

Source page: https://510kreport.com/device/K062143
Methodology: https://510kreport.com/methodology