# K011350: Starband Cranial Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jul 3, 2001 after 62 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
No predicates in its family tree.
31 later devices descend from it; 7 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082950: Starband (2008), 21 descendants of its own
- K014012: Doc Band (2002), 21 descendants of its own
- K072566: Hanger Cranial Band (2008), 20 descendants of its own
- K072862: Boston-Band Cranial Remodling Orthosis (2008), 18 descendants of its own
- K111609: Boston Band (2011), 16 descendants of its own

Source page: https://510kreport.com/device/K011350
Methodology: https://510kreport.com/methodology