# K041215: Cranial Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare LP
- Decided: Sep 9, 2004 after 122 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 DEN980001 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012804: Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis, Scott E Allen CP (2002) Summary page 2.

## Indications for use
The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. Contraindications: Infants with Synostosis or Hydrocephalus

Source page: https://510kreport.com/device/K041215
Methodology: https://510kreport.com/methodology