LOBO Vascular Occlusion System— 510(k) K260508
Substantially EquivalentOkami Medical, Inc.
FDA 510(k) clearance K260508 for LOBO Vascular Occlusion System, Substantially Equivalent on 2026-04-10. Applicant: Okami Medical, Inc.. Device class: 2.
Summary
The LOBO Vascular Occlusion System is an embolization device for closing off blood vessels, filed under KRD, vascular devices for promoting embolization. Occlusion devices like this are used in peripheral interventions to stop flow to a vessel or a bleeding site.
Class II, 21 CFR 870.3300. The Cardiovascular panel reviewed it as a Traditional 510(k).
Okami Medical filed from Aliso Viejo, California. Review took 52 days (February 17 to April 10, 2026). LOBO has earlier clearances, so a quick turnaround on a follow-up filing isn't surprising.
Clearance details
- Applicant
- Okami Medical, Inc.
- Product code
- Code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Recent devices under product code KRD
view allMore clearances from Okami Medical, Inc.
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.