# K041996: Nightform

- Pathway: 510(k) (Traditional)
- Applicant: Plastic Surgery Solutions, LLC
- Decided: Aug 3, 2004 after 8 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: 1 generation back to K905629 (1991). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905629: Pedicraft Infant Reflux Wedge, Pedicraft, Inc. (1991) Summary page 1.

## Most influential descendants
- K062143: Kozy Comfort Infant Positioner (2006), 1 descendant of its own
- K051300: Robin Hood Vest (2005), 1 descendant of its own
- K082367: Infant Sleep Beanie (2009), 0 descendants of its own

## Indications for use
The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, namely the condition known as deformational (or positional) plagiocephaly.

Source page: https://510kreport.com/device/K041996
Methodology: https://510kreport.com/methodology