# K014012: Doc Band

- Pathway: 510(k) (Traditional)
- Applicant: Cranial Technologies, Inc.
- Decided: Jan 28, 2002 after 54 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- 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). 2 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 24 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.
- K011350: Starband Cranial Orthosis, Orthomerica Products, Inc. (2001) Summary page 2.

## Most influential descendants
- K072566: Hanger Cranial Band (2008), 20 descendants of its own
- K111609: Boston Band (2011), 16 descendants of its own
- K124023: Starband (2013), 15 descendants of its own
- K133250: Starlight (2014), 14 descendants of its own
- K140353: Starband and Starlight (2014), 13 descendants of its own

## Indications for use
This device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K014012
Methodology: https://510kreport.com/methodology