Cleared Traditional

K262904 - INDIGO® Aspiration System

K262904 is an FDA 510(k) clearance for INDIGO Aspiration System, 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 58-day FDA review.

K262904 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
58d
Days
Class 2
Risk

K262904 is an FDA 510(k) clearance for the INDIGO® Aspiration System. 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 October 15, 2026 after a review of 58 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.

FDA 510(k) Submission Details - K262904

510(k) Number K262904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2026
Decision Date October 15, 2026
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05003843 Active not recruiting Interventional Industry-sponsored

BOLT-DVT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis

BOLT-DVT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

229
Patients (actual)
42
Sites
Treatment
Purpose
Open label
Masking
Condition studied Deep Vein Thrombosis; DVT
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Penumbra Inc. (industry)
Started 2021-09-30 → Primary completion 2025-11-18 → Completed 2028-01-01
Primary outcome
Composite of Major Adverse Events
Secondary outcome
Composite of Major Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 145
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K262904.
Triever Duo Catheter
K253419 · Inari Medical, Inc. · Sep 2026
Helo Max Thrombectomy System (HEL2090)
K261800 · Endovascular Engineering · Sep 2026
Artix™ MT
K262538 · Inari Medical, Inc. · Aug 2026
Vertex™ Thrombectomy System
K261523 · Jupiter Endovascular · Aug 2026
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
K262904 · INDIGO® Aspiration System
Download PDF FDA Summary Penumbra, Inc.