# K023572: Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Rehabilitation Institute,Loma Linda University Med
- Decided: Jan 13, 2003 after 81 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.
1 later device descends 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)
- K003035: Clarren Helmet, Children'S Hospital & Medical Center (2001) Summary page 2.

## Most influential descendants
- K070694: Ccro (Craniocephalic Custom Remolding Orthosis) (2007), 0 descendants of its own

## Indications for use
The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.

Source page: https://510kreport.com/device/K023572
Methodology: https://510kreport.com/methodology