Cleared Traditional

074 Zenith Flex System (K181354) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181354 · Inneuroco, Inc. · Neurology device
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Oct 2018
Decision
156d
Days
Class 2
Risk

K181354 is an FDA 510(k) clearance for the 074 Zenith Flex System. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Inneuroco, Inc. (Sunrise, US). The FDA issued a Cleared decision on October 25, 2018 after a review of 156 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 Inneuroco, Inc. devices

Submission Details

510(k) Number K181354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2018
Decision Date October 25, 2018
Days to Decision 156 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
8d slower than avg
Panel avg: 148d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K181354.
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464 · Stryker · Mar 2019
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 2018
Riptide Aspiration System (React 71 Catheter)
K182101 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Nov 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522 · Penumbra, Inc. · Oct 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · Penumbra, Inc. · Aug 2018
Riptide Aspiration System React 68 Catheter
K180705 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2018