# K003630: Danmar Products Michigan Cranial Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Danmar Products, Inc.
- Decided: May 29, 2001 after 186 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.
2 later devices descend from it; 2 cite 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090341: Michigan Cranial Reshaping Orthosis (2010), 0 descendants of its own
- K013452: Danmar Products Cranial Adjustive Prosthesis (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K003630
Methodology: https://510kreport.com/methodology