# K012920: Molded Cranial Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Fairview Orthopedic Laboratory
- Decided: Nov 28, 2001 after 90 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 DEN980001 (1998). 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)
- DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band, Cranial Technologies, Inc. (1998). Our OCR of the scanned summary read K964992, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980001, Dynamic Orthotic Cranioplasty Band; Doc Band (Cranial Technologies, Inc.), granted May 29, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K193383: SnugKap (2021), 0 descendants of its own

## Indications for use
The Molded Cranial Helmet is used to treat children 3-18 months of age for moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure o prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape. The device is for use by or on the order of a physician.

Source page: https://510kreport.com/device/K012920
Methodology: https://510kreport.com/methodology