Cleared Traditional

K192833 - Indigo Aspiration System

K192833 is the FDA 510(k) clearance for Indigo Aspiration System by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K192833 · Penumbra, Inc. · Cardiovascular device
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Dec 2019
Decision
79d
Days
Class 2
Risk

K192833 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 December 20, 2019 after a review of 79 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 Penumbra, Inc. devices

Submission Details

510(k) Number K192833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2019
Decision Date December 20, 2019
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT03218566 Completed Interventional Industry-sponsored

Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

119
Patients (actual)
22
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Akhilesh Sista, MD
Sponsor Penumbra Inc. (industry)
Started 2017-11-22 → Primary completion 2019-03-10 → Completed 2019-04-05
Primary outcome
Right Ventricle/Left Ventricle (RV:LV) Ratio
Secondary outcome
Device-related Death Rate
View full study on ClinicalTrials.gov

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 K192833.
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · Penumbra, Inc. · Apr 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · Penumbra, Inc. · Mar 2020
Capere Thrombectomy System
K200314 · Vascular Medcure, Inc. · Mar 2020
CAPERE Thrombectomy System
K192935 · Vascular Medcure, Inc. · Nov 2019
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
K192332 · Inari Medical · Sep 2019
FlowTriever Retrieval/Aspiration System
K191710 · Inari Medical · Sep 2019