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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 / K251744

510(k) cleared

Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter

Medtronic · Jan 16, 2026 · K251744

FDA cleared the Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter from Medtronic on Jan 16, 2026 under K251744, a special 510(k). The device falls under product code DTM, Filter, Blood, Cardiopulmonary Bypass, Arterial Line, regulated at 21 CFR 870.4260 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 6, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic 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 K251744?

K251744 is the FDA 510(k) for Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter, submitted by Medtronic. FDA's decision date was Jan 16, 2026, under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line).

Who makes the Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter?

Medtronic, based in Mounds View, MN, is the applicant of record for K251744.

How long did the K251744 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Jan 16, 2026, 224 days later.

← All decisions in January 2026