Cleared Special

Pounce Thrombectomy System (K220501) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220501 · Surmodics,Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
29d
Days
Class 2
Risk

K220501 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 March 23, 2022 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surmodics,Inc. devices

Submission Details

510(k) Number K220501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date March 23, 2022
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K220501.
Triever24, Triever20
K213402 · Inari Medical · May 2022
Prodigy Thrombectomy System
K214114 · Truvic Medical, Inc. · Apr 2022
Artix Thrombectomy Device
K220600 · Inari Medical · Mar 2022
Cleaner Plus Thrombectomy System
K211798 · Argon Medical Devices, Inc. · Feb 2022
WOLF Thrombectomy System, 14F
K210911 · Devoro Medical, Inc. · Oct 2021
ClotTriever Thrombectomy System
K212632 · Inari Medical, Inc. · Oct 2021