# K203134: Hanger Cranial Band 3D

- Pathway: 510(k) (Traditional)
- Applicant: Symbion Logistics, LLC
- Decided: Jul 1, 2022 after 620 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: 3 generations back to DEN980001 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072566: Hanger Cranial Band, Hanger Prosthetics & Orthotics, Inc. (2008) Summary page 4.

## 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. Contraindications for use: Infants with synostosis or hydrocephalus.

Source page: https://510kreport.com/device/K203134
Methodology: https://510kreport.com/methodology