Cleared Traditional

K161506 - Penumbra Aspiration System

K161506 is an FDA 510(k) clearance for Penumbra Aspiration System, manufactured by Penumbra, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K161506 · Penumbra, Inc. · Cardiovascular device
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Sep 2016
Decision
117d
Days
Class 2
Risk

K161506 is an FDA 510(k) clearance for the Penumbra Aspiration System. 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 September 26, 2016 after a review of 117 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K161506

510(k) Number K161506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date September 26, 2016
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 131
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K161506.
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
K173470 · Inari Medical · Dec 2017
ClotTriever Thrombectomy System
K163549 · Inari Medical, Inc. · Feb 2017
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
K162970 · Inari Medical · Nov 2016
INDIGO Aspiration System
K161523 · Penumbra, Inc. · Jul 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · Penumbra, Inc. · May 2016
ZelanteDVT Thrombectomy Set
K151313 · Boston Scientific Corporation · Sep 2015