FDA applicant
Okami Medical, Inc.
FDA records 8 decisions for Okami Medical, Inc. (Aliso Viejo, CA) from 2019 to 2026: 8 510(k) clearances. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Okami Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Okami Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Okami Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report