Cleared Traditional

Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (K180412) - FDA 510(k) Clearance

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

K180412 · Penumbra, Inc. · Cardiovascular device
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May 2018
Decision
89d
Days
Class 2
Risk

K180412 is an FDA 510(k) clearance for the Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and C.... 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 15, 2018 after a review of 89 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 Penumbra, Inc. devices

Submission Details

510(k) Number K180412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date May 15, 2018
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K180412.
FlowTriever Retrieval/Aspiration System
K181325 · Inari Medical, Inc. · Jun 2018
CAPERE Thrombectomy System
K180722 · Kp Medcure, Inc. · Jun 2018
FlowTriever Retrieval/Aspiration System
K180466 · Inari Medical, Inc. · May 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · Penumbra, Inc. · May 2018
ClotTriever Thrombectomy System
K180329 · Inari Medical, Inc. · Apr 2018
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
K180105 · Penumbra, Inc. · Mar 2018