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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 / K251676

510(k) cleared

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

Microtek Medical, LLC · Sep 16, 2025 · K251676

FDA cleared the Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) from Microtek Medical, LLC on Sep 16, 2025 under K251676, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LHI, Set, I.V. Fluid Transfer, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 30, 2025. The decision came 109 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 Microtek Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251676?

K251676 is the FDA 510(k) for Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S), submitted by Microtek Medical, LLC. FDA's decision date was Sep 16, 2025, under product code LHI (Set, I.V. Fluid Transfer).

Who makes the Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)?

Microtek Medical, LLC, based in Northfiled, IL, is the applicant of record for K251676.

How long did the K251676 review take?

FDA received the submission on May 30, 2025 and issued its decision on Sep 16, 2025, 109 days later.

← All decisions in September 2025