# K001167: Opi Band

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jul 7, 2000 after 88 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
No predicates in its family tree.
31 later devices descend from it; 5 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
- K021207: Starlight (2002), 25 descendants of its own
- K081994: Starlight (2008), 24 descendants of its own
- K082950: Starband (2008), 21 descendants of its own
- K111609: Boston Band (2011), 16 descendants of its own
- K082945: Starlight (2008), 16 descendants of its own

Source page: https://510kreport.com/device/K001167
Methodology: https://510kreport.com/methodology