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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture), K260195 (Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae).

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