Cleared Traditional

K180222 - Reaxon Plus

K180222 is an FDA 510(k) clearance for Reaxon Plus, manufactured by Medovent GmbH. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K180222 · Medovent GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
89d
Days
Class 2
Risk

K180222 is an FDA 510(k) clearance for the Reaxon Plus. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Medovent GmbH (Mainz, DE). The FDA issued a Cleared decision on April 24, 2018 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medovent GmbH devices

FDA 510(k) Submission Details - K180222

510(k) Number K180222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2018
Decision Date April 24, 2018
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 K180222.
NervAlign Nerve Cuff
K202234 · Renerve, Ltd. · Feb 2022
VersaWrap Nerve Protector
K201631 · Alafair Biosciences, Inc. · Sep 2020
NeuroShield
K190246 · Monarch Bioimplants GmbH · May 2019
AxoGen Nerve Cap
K163446 · Axogen Corporation · Aug 2017
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017