# K070694: Ccro (Craniocephalic Custom Remolding Orthosis)

- Pathway: 510(k) (Traditional)
- Applicant: Mike Miner
- Decided: Sep 10, 2007 after 181 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 K003035 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023572: Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet, Rehabilitation Institute,Loma Linda University Med (2003) Summary page 1.
- K030669: Providence Molding Helmet, Northeast Orthotics and Prothetics, Inc. (2003) Summary page 1.
- K003035: Clarren Helmet, Children'S Hospital & Medical Center (2001) Summary page 1.

## Indications for use
The Craniocephalic Custom Remolding Orthosis (CORO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.

Source page: https://510kreport.com/device/K070694
Methodology: https://510kreport.com/methodology