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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Imperative Care, Inc. has one other decision in the tracker over the last 12 months: K261176 (Zoom 4S Catheter).

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

Sources