Cleared Special

K152097 - Retraction Aspirator

K152097 is the FDA 510(k) clearance for Retraction Aspirator by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K152097 · Inari Medical · Cardiovascular device
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Aug 2015
Decision
28d
Days
Class 2
Risk

K152097 is an FDA 510(k) clearance for the Retraction Aspirator. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on August 25, 2015 after a review of 28 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.

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Submission Details

510(k) Number K152097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date August 25, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 127
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K152097.
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
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · Penumbra, Inc. · May 2015
ANGIOJET ULTRA AVX THROMBECTOMY SET
K133629 · Possis Medical, Inc. · Feb 2014
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013