# K021918: Clarren Helmet (Orthomerica)

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jul 25, 2002 after 44 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Clarren Helmet (Children’s Hospital): named in the summary without a submission number

## Most influential descendants
- K133397: P-POD (2014), 1 descendant of its own
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The Clarren 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/K021918
Methodology: https://510kreport.com/methodology