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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 / October 2025 / K250325

510(k) cleared

BD Alaris Pump Infusion Set

Carefusion (Bd) · Oct 30, 2025 · K250325

FDA cleared the BD Alaris Pump Infusion Set from Carefusion (Bd) on Oct 30, 2025 under K250325, a traditional 510(k). The device falls under product code FPA, Set, Administration, Intravascular, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Feb 5, 2025. The decision came 267 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 Carefusion (Bd) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250325?

K250325 is the FDA 510(k) for BD Alaris Pump Infusion Set, submitted by Carefusion (Bd). FDA's decision date was Oct 30, 2025, under product code FPA (Set, Administration, Intravascular).

Who makes the BD Alaris Pump Infusion Set?

Carefusion (Bd), based in San Diego, CA, is the applicant of record for K250325.

How long did the K250325 review take?

FDA received the submission on Feb 5, 2025 and issued its decision on Oct 30, 2025, 267 days later.

← All decisions in October 2025