Cleared Traditional

K203440 - Penumbra System (Reperfusion Catheter R...

K203440 is an FDA 510(k) clearance for Penumbra System (Reperfusion Catheter R..., manufactured by Penumbra, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K203440 · Penumbra, Inc. · Neurology device
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May 2021
Decision
178d
Days
Class 2
Risk

K203440 is an FDA 510(k) clearance for the Penumbra System (Reperfusion Catheter RED 62). Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 20, 2021 after a review of 178 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Penumbra, Inc. devices

FDA 510(k) Submission Details - K203440

510(k) Number K203440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date May 20, 2021
Days to Decision 178 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 148d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NRY Device Classification - Class 2, Special Controls

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 106
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K203440.
EMBOTRAP III Revascularization Device
K211338 · Neuravi, Ltd. · Jul 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · Penumbra, Inc. · Jul 2021
ZOOM 71 Reperfusion Catheter
K211476 · Imperative Care, Inc. · Jun 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K210996 · Imperative Care, Inc. · Apr 2021
Tigertriever and Tigertriever 17 Revascularization Devce
K203592 · Rapid Medical , Ltd. · Mar 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182 · Imperative Care, Inc. · Sep 2020