# K082367: Infant Sleep Beanie

- Pathway: 510(k) (Traditional)
- Applicant: Life Innovations, LLC
- Decided: Jun 12, 2009 after 298 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: 3 generations back to K905629 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062143: Kozy Comfort Infant Positioner, Alfred E Mann Inst. For Biomedical Engineering (2006) Summary page 1.
- K060986: Head Bed, Steven H. Warnock, M.D. (2006) Summary page 1.
- K051300: Robin Hood Vest, Kamber Corporation (2005) Summary page 1.
- K041996: Nightform, Plastic Surgery Solutions, LLC (2004) Summary page 1.

## Indications for use
The Life Innovations Infant Sleep Beanie is an over-the-counter repositioning device to aid ift the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.

Source page: https://510kreport.com/device/K082367
Methodology: https://510kreport.com/methodology