Cleared Special

K241399 - Indigo Lightning Flash Aspiration Syste...

K241399 is the FDA 510(k) clearance for Indigo Lightning Flash Aspiration Syste... by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 25-day FDA review.

K241399 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
25d
Days
Class 2
Risk

K241399 is an FDA 510(k) clearance for the Indigo® Lightning Flash Aspiration System – Select +™ Catheter. 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 June 10, 2024 after a review of 25 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 Penumbra, Inc. devices

Submission Details

510(k) Number K241399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2024
Decision Date June 10, 2024
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 125
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K241399.
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · Surmodics,Inc. · Sep 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · Penumbra, Inc. · Sep 2024
ICHOR 7F Embolectomy System (ICH-7F)
K233917 · Ichor · Jul 2024
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
K241207 · Devoro Medical, Inc. · May 2024
ICE Aspiration System
K234073 · Expanse Medical, Inc. · Apr 2024
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister
K233909 · Argon Medical Devices, Inc. · Mar 2024