# K072566: Hanger Cranial Band

- Pathway: 510(k) (Traditional)
- Applicant: Hanger Prosthetics & Orthotics, Inc.
- Decided: Jan 9, 2008 after 119 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: 2 generations back to DEN980001 (1998). 3 ancestors in all.
20 later devices descend from it; 4 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)
- K014012: Doc Band, Cranial Technologies, Inc. (2002) Summary page 3.

## Most influential descendants
- 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
- K141842: Starband, Starlight (2014), 10 descendants of its own

## Indications for use
Intended for medical purposes to apply static or gentle 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/K072566
Methodology: https://510kreport.com/methodology