Cleared Traditional

K121917 - PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

K121917 is the FDA 510(k) clearance for PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K121917 · Penumbra, Inc. · Cardiovascular device
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Sep 2012
Decision
79d
Days
Class 2
Risk

K121917 is an FDA 510(k) clearance for the PENUMBRA EMBOLECTOMY 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 19, 2012 after a review of 79 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 K121917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date September 19, 2012
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 K121917.
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · Penumbra, Inc. · May 2015
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · Medrad, Inc. · Jul 2013
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · Arrow Intl., Inc. · Oct 2001