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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 / January 2026 / K251831

510(k) cleared

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc. · Jan 15, 2026 · K251831

FDA cleared the Bio-Medicus Life Support Catheter and Introducer from Medtronic, Inc. on Jan 15, 2026 under K251831, a traditional 510(k). The device falls under product code QHW, Single Lumen Ecmo Cannula, regulated at 21 CFR 870.4100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 13, 2025. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K251831?

K251831 is the FDA 510(k) for Bio-Medicus Life Support Catheter and Introducer, submitted by Medtronic, Inc.. FDA's decision date was Jan 15, 2026, under product code QHW (Single Lumen Ecmo Cannula).

Who makes the Bio-Medicus Life Support Catheter and Introducer?

Medtronic, Inc., based in Minneapolis, MN, is the applicant of record for K251831.

How long did the K251831 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Jan 15, 2026, 216 days later.

← All decisions in January 2026