Cleared Traditional

K222358 - Indigo Aspiration System - Lightning Flash

K222358 is an FDA 510(k) clearance for Indigo Aspiration System - Lightning Flash, 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 138-day FDA review.

K222358 · Penumbra, Inc. · Cardiovascular device
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Dec 2022
Decision
138d
Days
Class 2
Risk

K222358 is an FDA 510(k) clearance for the Indigo Aspiration System - Lightning Flash. 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 December 20, 2022 after a review of 138 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 - K222358

510(k) Number K222358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2022
Decision Date December 20, 2022
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
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 K222358.
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · Penumbra, Inc. · Feb 2023
ClotTriever Thrombectomy System
K221531 · Inari Medical, Inc. · Feb 2023
Artix BG
K223000 · Inari Medical · Jan 2023
WOLF Thrombectomy™ SmartClaw Catheter
K221391 · Devoro Medical, Inc. · Nov 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · Penumbra, Inc. · Oct 2022
Mini-ClotTriever Thrombectomy System
K220887 · Inari Medical · Aug 2022