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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 / K252046

510(k) cleared

Zoom System (Zoom 4S Catheter)

Imperative Care, Inc. · Oct 30, 2025 · K252046

FDA cleared the Zoom System (Zoom 4S Catheter) from Imperative Care, Inc. on Oct 30, 2025 under K252046, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 30, 2025. The decision came 122 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 Imperative Care, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252046?

K252046 is the FDA 510(k) for Zoom System (Zoom 4S Catheter), submitted by Imperative Care, Inc.. FDA's decision date was Oct 30, 2025, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Zoom System (Zoom 4S Catheter)?

Imperative Care, Inc., based in Campbell, CA, is the applicant of record for K252046.

How long did the K252046 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Oct 30, 2025, 122 days later.

← All decisions in October 2025