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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 / August 2026 / K260246

510(k) cleared

SEISMIQ Intravascular Lithotripsy System

Bolt Medical, Inc. · Aug 24, 2026 · K260246 · In the directory

FDA cleared the SEISMIQ Intravascular Lithotripsy System from Bolt Medical, Inc. on Aug 24, 2026 under K260246, a traditional 510(k). The device falls under product code PPN, Percutaneous Catheter, Ultrasound, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 27, 2026. The decision came 209 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K260246?

K260246 is the FDA 510(k) for SEISMIQ Intravascular Lithotripsy System, submitted by Bolt Medical, Inc.. FDA's decision date was Aug 24, 2026, under product code PPN (Percutaneous Catheter, Ultrasound).

Who makes the SEISMIQ Intravascular Lithotripsy System?

Bolt Medical, Inc., based in Carlsbad, CA, is the applicant of record for K260246. The company is listed in the MedDevice Startups directory.

How long did the K260246 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Aug 24, 2026, 209 days later.

← All decisions in August 2026

Sources

In the startup directory

Bolt Medical

Cardiovascular · Carlsbad, CA