# K003035: Clarren Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Children'S Hospital & Medical Center
- Decided: Jun 6, 2001 after 251 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023572: Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet (2003), 1 descendant of its own
- K070694: Ccro (Craniocephalic Custom Remolding Orthosis) (2007), 0 descendants of its own
- K022273: Cranial Symmetry System (2002), 0 descendants of its own
- K012007: RHS Helmet (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K003035
Methodology: https://510kreport.com/methodology