Cleared Traditional

K250421 - InThrill Thrombectomy System

K250421 is the FDA 510(k) clearance for InThrill Thrombectomy System by Inari Medical, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K250421 · Inari Medical, Inc. · Cardiovascular device
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May 2025
Decision
88d
Days
Class 2
Risk

K250421 is an FDA 510(k) clearance for the InThrill™ Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 12, 2025 after a review of 88 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 Inari Medical, Inc. devices

Submission Details

510(k) Number K250421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date May 12, 2025
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K250421.
Excipio LV Prime Thrombectomy Device
K251485 · Contego Medical, Inc. · Jun 2025
Liberant Thrombectomy System
K250787 · Medtronic, Ireland · Jun 2025
Symphony™ Thrombectomy System
K250775 · Imperative Care, Inc. · May 2025
Aventus Thrombectomy System (IM-2100)
K250668 · Inquis Medical · Mar 2025
FlowTriever2 Catheter
K250088 · Inari Medical, Inc. · Mar 2025
Aventus Thrombectomy System
K250202 · Inquis Medical · Feb 2025