Cleared Traditional

Zoom System (Zoom 4S Catheter)

K252046 · Imperative Care, Inc. · Neurology

Oct 2025

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K252046 is an FDA 510(k) clearance for the Zoom System (Zoom 4S Catheter), a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on October 30, 2025, 122 days after receiving the submission on June 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K252046 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	October 30, 2025
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.