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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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).

Okami Medical, Inc. has one other decision in the tracker over the last 12 months: K262798 (LOBO Vascular Occlusion System).

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