Cleared Traditional

Pounce Thrombectomy System (K211492) - FDA 510(k) Clearance

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

K211492 · Surmodics,Inc. · Cardiovascular device
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Jul 2021
Decision
78d
Days
Class 2
Risk

K211492 is an FDA 510(k) clearance for the Pounce Thrombectomy 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 July 30, 2021 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surmodics,Inc. devices

Submission Details

510(k) Number K211492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2021
Decision Date July 30, 2021
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 K211492.
WOLF Thrombectomy System, 14F
K210911 · Devoro Medical, Inc. · Oct 2021
ClotTriever Thrombectomy System
K212632 · Inari Medical, Inc. · Oct 2021
WOLF Thrombectomy System, 6F
K210530 · Devoro Medical, Inc. · Aug 2021
ClotTriever Thrombectomy System
K210689 · Inari Medical, Inc. · May 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
K211013 · Inari Medical, Inc. · Apr 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · Penumbra, Inc. · Feb 2021