Cleared Traditional

K190246 - NeuroShield

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

K190246 · Monarch Bioimplants GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K190246

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.

JXI Device Classification - Class 2, Special Controls

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 35
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
AxoGen Nerve Cap
K163446 · Axogen Corporation · Aug 2017
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017