# K060986: Head Bed

- Pathway: 510(k) (Traditional)
- Applicant: Steven H. Warnock, M.D.
- Decided: Jul 11, 2006 after 92 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NightForm Infant Sleep Positioner: named in the summary without a submission number

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

## Indications for use
The Head Bed T M infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.

Source page: https://510kreport.com/device/K060986
Methodology: https://510kreport.com/methodology