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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K260508

510(k) cleared

LOBO Vascular Occlusion System

Okami Medical, Inc. · Apr 10, 2026 · K260508 · In the directory

FDA cleared the LOBO Vascular Occlusion System from Okami Medical, Inc. on Apr 10, 2026 under K260508, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 17, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Okami Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260508?

K260508 is the FDA 510(k) for LOBO Vascular Occlusion System, submitted by Okami Medical, Inc.. FDA's decision date was Apr 10, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the LOBO Vascular Occlusion System?

Okami Medical, Inc., based in Aliso Viejo, CA, is the applicant of record for K260508. The company is listed in the MedDevice Startups directory.

How long did the K260508 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Apr 10, 2026, 52 days later.

← All decisions in April 2026

Sources

In the startup directory

Okami Medical

Cardiovascular · Aliso Viejo, CA