Cleared Traditional

K190246 - NeuroShield (FDA 510(k) Clearance)

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

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

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

Submitted by Monarch Bioimplants GmbH (Root, CH). The FDA issued a Cleared decision on May 31, 2019, 114 days after receiving the submission on February 6, 2019.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.

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
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 162d · 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.