# K013458: Cranial Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Children'S Hospital
- Decided: Oct 29, 2001 after 11 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Gillette Children’s Specialty Healthcare - CranioCap™: named in the summary without a submission number

## Indications for use
The Children’s Hospital cranial helmet is intended to apply passive pressure o prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K013458
Methodology: https://510kreport.com/methodology