# K013452: Danmar Products Cranial Adjustive Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Danmar Products, Inc.
- Decided: Oct 31, 2003 after 743 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 K003630 (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)
- K003630: Danmar Products Michigan Cranial Helmet, Danmar Products, Inc. (2001) Summary page 1.
- (no number) Cranial Technologies Dynamic Orthotic Cranioplasty--DOC Band: named in the summary without a submission number

## Indications for use
The Danmar. Products Cranial Adjustive Prosthesis is intenc ?( for prescription use to be used to apply pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.

Source page: https://510kreport.com/device/K013452
Methodology: https://510kreport.com/methodology