WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / January 2026 / K253998

510(k) cleared

Clearview Intracoronary Shunts

Medtronic, Inc. · Jan 20, 2026 · K253998

FDA cleared the Clearview Intracoronary Shunts from Medtronic, Inc. on Jan 20, 2026 under K253998, a special 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 12, 2025. The decision came 39 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface).

Questions & Answers

What did FDA clear under K253998?

K253998 is the FDA 510(k) for Clearview Intracoronary Shunts, submitted by Medtronic, Inc.. FDA's decision date was Jan 20, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Clearview Intracoronary Shunts?

Medtronic, Inc., based in Mounds View, MN, is the applicant of record for K253998.

How long did the K253998 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Jan 20, 2026, 39 days later.

← All decisions in January 2026