Data / Medical devices / United States / Okami Medical Inc.
Okami Medical Inc.: FDA-registered device maker in Aliso Viejo, CA, United States, 6 510(k) clearances
Okami Medical Inc. is registered with the FDA (registration 3016444913) in Aliso Viejo, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016444913
- Address
- 8 Argonaut Suite 100, Aliso Viejo, CA, United States, 92656
- Owner or operator
- Okami Medical Inc. (10061852)
- Roles
- Manufacturer
- First device listed
- November 25, 2019
- Registered through
- 2026
- Brand names listed
- LOBO Handpiece (LOBO-HP), LOBO Vascular Occluder (LOBO-3), LOBO Vascular Occluder (LOBO-5), LOBO Vascular Occluder (LOBO-7), LOBO Vascular Occluder (LOBO-9), LOBO Vascular Occlusion System (LOBO-3-LP), SENDERO MAX Delivery Catheter (SENDERO-MAX55-110MP), SENDERO Microcatheter (2.9F)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K260508 | LOBO Vascular Occlusion System | KRD | Substantially Equivalent | Okami Medical, Inc. | accessdata.fda.gov |
| December 20, 2024 | K242644 | SENDERO MAX Delivery Catheter | DQY | Substantially Equivalent | Okami Medical, Inc. | accessdata.fda.gov |
| March 8, 2024 | K240384 | SENDERO Microcatheter | DQY | Substantially Equivalent | Okami Medical, Inc. | accessdata.fda.gov |
| April 29, 2022 | K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | KRD | Substantially Equivalent | Okami Medical | accessdata.fda.gov |
| November 5, 2020 | K203025 | LOBO Vascular Occlusion System (model LOBO-5) | KRD | Substantially Equivalent | Okami Medical | accessdata.fda.gov |
| October 30, 2019 | K192083 | Okami Medical LOBO Vascular Occlusion System | KRD | Substantially Equivalent | Okami Medical | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.