# Okami Medical, Inc.

- Location (FDA's records): Aliso Viejo, CA
- FDA decisions: 8 (2019–2026): 8 510(k) clearances
- Names in FDA's records: Okami Medical, Inc. (5); Okami Medical (3)
- Product codes: KRD (5), DQY (3)
- 510(k) review time since 2016: median 69 days, against 101 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 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
- MicroVention, Inc. A TERUMO Group Company: 1 (https://510kreport.com/company/microvention-a-terumo-group)

## Its most-cited devices
- K240384: SENDERO Microcatheter (2024), cited by 1
- K192083: Okami Medical LOBO Vascular Occlusion System (2019), cited by 1
- K231600: SENDERO Microcatheter (2023), cited by 1

## Recent decisions
- K262798: LOBO Vascular Occlusion System (Oct 6, 2026)
- K260508: LOBO Vascular Occlusion System (Apr 10, 2026)
- K242644: SENDERO MAX Delivery Catheter (Dec 20, 2024)
- K240384: SENDERO Microcatheter (Mar 8, 2024)
- K231600: SENDERO Microcatheter (Nov 17, 2023)
- K220383: LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) (Apr 29, 2022)
- K203025: LOBO Vascular Occlusion System (model LOBO-5) (Nov 5, 2020)
- K192083: Okami Medical LOBO Vascular Occlusion System (Oct 30, 2019)

Source page: https://510kreport.com/company/okami-medical