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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 / September 2025 / K251812

510(k) cleared

Steripath® Flow Blood Collection System

Magnolia Medical Technologies · Sep 25, 2025 · K251812

FDA cleared the Steripath® Flow Blood Collection System from Magnolia Medical Technologies on Sep 25, 2025 under K251812, a traditional 510(k). The device falls under product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection, regulated at 21 CFR 862.1675 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 12, 2025. The decision came 105 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 Magnolia Medical Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251812?

K251812 is the FDA 510(k) for Steripath® Flow Blood Collection System, submitted by Magnolia Medical Technologies. FDA's decision date was Sep 25, 2025, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the Steripath® Flow Blood Collection System?

Magnolia Medical Technologies, based in Seattle, WA, is the applicant of record for K251812.

How long did the K251812 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Sep 25, 2025, 105 days later.

← All decisions in September 2025