# K042385: Doc Band-Postop

- Pathway: 510(k) (Traditional)
- Applicant: Cranial Technologies, Inc.
- Decided: Dec 17, 2004 after 107 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 reading of the summary gave 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
- K244056: DOC Band 3D (2025), 0 descendants of its own

## Indications for use
This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Source page: https://510kreport.com/device/K042385
Methodology: https://510kreport.com/methodology