# K063395: O&P Bivalve Cranial Molding Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Orthotic & Prosthetic Lab, Inc.
- Decided: Dec 22, 2006 after 43 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.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013700: Orthosis Helmet Molding, Precision Prosthetics & Orthotics, Inc. (2002) Summary page 2.

## Most influential descendants
- K161138: St. Louis Band (2016), 4 descendants of its own
- K180109: STARband, STARlight, St. Louis Band (2018), 3 descendants of its own
- K213587: MyCRO Band (2022), 0 descendants of its own
- K193383: SnugKap (2021), 0 descendants of its own
- K201426: MyCRO Band (2021), 0 descendants of its own

## Indications for use
The O&P Bivalve Cranial Molding Helmet is 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, brachycephalic and scaphocephalic shaped heads.

Source page: https://510kreport.com/device/K063395
Methodology: https://510kreport.com/methodology