# Ortho8, Inc.

- Location (FDA's records): Rocklin, CA
- FDA decisions: 3 (2021–2022): 3 510(k) clearances
- Product codes: JOW (3)
- 510(k) review time since 2016: median 80 days, against 132 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Innovamed Health, LLC: 1 (https://510kreport.com/company/innovamed-health)
- Vena Group, LLC: 1 (https://510kreport.com/company/vena-group)
- Manamed, Inc.: 1 (https://510kreport.com/company/manamed)

## Recent decisions
- K220761: CIRCUL8 Connect DVT Prevention Device (Jun 3, 2022)
- K212731: Circul8 Pro (Nov 15, 2021)
- K211235: CIRCUL8 Luxe DVT Prevention Device (Sep 8, 2021)

Source page: https://510kreport.com/company/ortho8