Cleared Traditional

K192981 - Indigo System Aspiration Catheter 12

K192981 is the FDA 510(k) clearance for Indigo System Aspiration Catheter 12 by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K192981 · Penumbra, Inc. · Cardiovascular device
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May 2020
Decision
217d
Days
Class 2
Risk

K192981 is an FDA 510(k) clearance for the Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 28, 2020 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Penumbra, Inc. devices

Submission Details

510(k) Number K192981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2019
Decision Date May 28, 2020
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 125
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K192981.
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
WOLF Thrombectomy V System
K200101 · Devoro Medical, Inc. · Apr 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · Penumbra, Inc. · Apr 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · Penumbra, Inc. · Mar 2020