# K012007: RHS Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Health Svs, Inc.
- Decided: Sep 19, 2001 after 84 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 K003035 (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)
- K003035: Clarren Helmet, Children'S Hospital & Medical Center (2001) Summary page 1.

## Indications for use
The RHS Helmet is a cranial orthosis that applies passive 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/K012007
Methodology: https://510kreport.com/methodology