# K240466: STARband 3D

- Pathway: 510(k) (Special)
- Applicant: Orthomerica Products, Inc.
- Decided: Mar 15, 2024 after 28 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: 6 generations back to K001167 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223238: STARband 3D, Orthomerica Products, Inc. (2023) Summary page 5.

## Indications for use
The STARband® 3D™ s intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant’s cranium to improve cranial symmetry and/or shape.

Source page: https://510kreport.com/device/K240466
Methodology: https://510kreport.com/methodology