Cleared Traditional

K190246 - NeuroShield

K190246 is the FDA 510(k) clearance for NeuroShield by Monarch Bioimplants GmbH. It is a Class 2 Neurology device (product code JXI) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K190246 · Monarch Bioimplants GmbH · Neurology device
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May 2019
Decision
114d
Days
Class 2
Risk

K190246 is an FDA 510(k) clearance for the NeuroShield. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Monarch Bioimplants GmbH (Root, CH). The FDA issued a Cleared decision on May 31, 2019 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - 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 Monarch Bioimplants GmbH devices

Submission Details

510(k) Number K190246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2019
Decision Date May 31, 2019
Days to Decision 114 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
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
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 - JXI Cuff, Nerve

All 23
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K190246.
Nerve Tape
K210665 · Biocircuit Technologies, Incorporated · Jul 2022
NervAlign Nerve Cuff
K202234 · Renerve, Ltd. · Feb 2022
VersaWrap Nerve Protector
K201631 · Alafair Biosciences, Inc. · Sep 2020
Reaxon Plus
K180222 · Medovent GmbH · Apr 2018
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017