# K103362: Aoi Cranial Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopro, Inc.
- Decided: Apr 18, 2011 after 152 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 K001167 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001167: Opi Band, Orthomerica Products, Inc. (2000) Summary page 1.

## Indications for use
The A0l Cranial Helmet is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.

Source page: https://510kreport.com/device/K103362
Methodology: https://510kreport.com/methodology