Cleared Traditional

Pounce Thrombus Retrieval System (K192814) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 119
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