Cleared Special

K180105 - Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister

K180105 is an FDA 510(k) clearance for Indigo Aspiration System - Penumbra Eng..., manufactured by Penumbra, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Special 510(k) pathway after a 51-day FDA review.

K180105 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
51d
Days
Class 2
Risk

K180105 is an FDA 510(k) clearance for the Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - P.... 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 March 8, 2018 after a review of 51 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.

FDA 510(k) Submission Details - K180105

510(k) Number K180105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date March 08, 2018
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

QEW Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K180105.
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
K180412 · Penumbra, Inc. · May 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · Penumbra, Inc. · May 2018
ClotTriever Thrombectomy System
K180329 · Inari Medical, Inc. · Apr 2018
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · Inari Medical · Feb 2018
V2K Rinspiration System
K172716 · V2k Medical, Inc. · Jan 2018
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
K173470 · Inari Medical · Dec 2017