Cleared Special

K152097 - Retraction Aspirator

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

K152097 · Inari Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Inari Medical devices

FDA 510(k) Submission Details - K152097

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 136
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
Infusion Aspiration Catheter System
K143563 · Inari Medical, Inc. · Feb 2015
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · Rex Medical, L.P. · Nov 2014