# K021221: O&P Cranical Molding Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Orthotic & Prosthetic Lab, Inc.
- Decided: Jul 1, 2002 after 75 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: 1 generation back to K011350 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011350: Starband Cranial Orthosis, Orthomerica Products, Inc. (2001)

## Indications for use
Intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

Source page: https://510kreport.com/device/K021221
Methodology: https://510kreport.com/methodology