Okami Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Okami Medical, Inc.” (first 2019, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 78 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 89 |
| 2020 | 1 | 34 |
| 2021 | 0 | — |
| 2022 | 1 | 78 |
| 2023 | 1 | 169 |
| 2024 | 2 | 68 |
| 2025 | 0 | — |
| 2026 | 1 | 52 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Okami Medical, Inc. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
Review panels
- Cardiovascular (7)
Most recent Okami Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260508 | LOBO Vascular Occlusion System | KRD | 2026-04-10 | 52 |
| K242644 | SENDERO MAX Delivery Catheter | DQY | 2024-12-20 | 108 |
| K240384 | SENDERO Microcatheter | DQY | 2024-03-08 | 29 |
| K231600 | SENDERO Microcatheter | DQY | 2023-11-17 | 169 |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | KRD | 2022-04-29 | 78 |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | KRD | 2020-11-05 | 34 |
| K192083 | Okami Medical LOBO Vascular Occlusion System | KRD | 2019-10-30 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Okami Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Okami Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07525518: Okami Medical ALPHA Registry (Enrolling by invitation, started 2026-03-31)
Frequently asked questions
How many FDA 510(k) clearances are listed under Okami Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Okami Medical, Inc.” (first 2019, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Okami Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Okami Medical, Inc. is 78 days. Since 2017: 78 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Okami Medical, Inc.?
The most frequent FDA product codes under this applicant name are KRD (Device, Vascular, For Promoting Embolization, 4); DQY (Catheter, Percutaneous, 3).
Next steps
- See all 7 Okami Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRD, Okami Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.