Cleared Traditional

K192814 - Pounce Thrombus Retrieval System

K192814 is an FDA 510(k) clearance for Pounce Thrombus Retrieval System, manufactured by Surmodics,Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K192814 · Surmodics,Inc. · Cardiovascular device
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Sep 2020
Decision
356d
Days
Class 2
Risk

K192814 is an FDA 510(k) clearance for the Pounce Thrombus Retrieval System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Surmodics,Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 21, 2020 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Surmodics,Inc. devices

FDA 510(k) Submission Details - K192814

510(k) Number K192814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date September 21, 2020
Days to Decision 356 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 125d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 131
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K192814.
FlowTriever Retrieval/Aspiration System
K201541 · Inari Medical · Dec 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · Penumbra, Inc. · Nov 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · Boston Scientific Corporation · Oct 2020
ClotTriever Thrombectomy System
K193462 · Inari Medical · Sep 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · Penumbra, Inc. · Aug 2020
CAPERE Thrombectomy System
K201216 · Vascular Medcure, Inc. · Jul 2020