WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252580

510(k) cleared

iQ200 Series

Beckman Coulter, Inc. · Sep 10, 2025 · K252580

FDA cleared the iQ200 Series from Beckman Coulter, Inc. on Sep 10, 2025 under K252580, a special 510(k). The device falls under product code LKM, Counter, Urine Particle, regulated at 21 CFR 864.5200 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Aug 15, 2025. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Beckman Coulter, Inc. has 6 other decisions in the tracker over the last 12 months: K252169 (Access BNP II), K254059 (Access anti-HBc IgM), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM).

Questions & Answers

What did FDA clear under K252580?

K252580 is the FDA 510(k) for iQ200 Series, submitted by Beckman Coulter, Inc.. FDA's decision date was Sep 10, 2025, under product code LKM (Counter, Urine Particle).

Who makes the iQ200 Series?

Beckman Coulter, Inc., based in Miami, FL, is the applicant of record for K252580.

How long did the K252580 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Sep 10, 2025, 26 days later.

← All decisions in September 2025

Sources