# K180568: KidCap

- Pathway: 510(k) (Traditional)
- Applicant: Eastern Cranial Affiliates, LLC
- Decided: Oct 16, 2018 after 225 days
- Product code: MVA (Orthosis, Cranial)
- Device class: 2
- Regulation: 21 CFR 882.5970
- 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 DEN980001 (1998). 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)
- K020448: Static Cranioplasty Orthosis, Eastern Cranial Affiliates (2002) Summary page 4.

## Most influential descendants
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The KidCap™ is a cranial orthosis used to treat abnormally shaped craniums in infants between the ages of three (3) months to eighteen (18) months of age. It is designed to address abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly. It includes infants with plagiocephalic, brachycephalic and scaphocephalic patterned head shapes, and post-operative craniosynostosis management. The KidCap™ utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium, but will not initiate a force upon the cranium. The KidCap™ is only available if prescribed by a physician.

Source page: https://510kreport.com/device/K180568
Methodology: https://510kreport.com/methodology