Cleared Traditional

K143711 - Reaxon Plus

K143711 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 338-day FDA review.

K143711 · Medovent GmbH · Neurology device
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Dec 2015
Decision
338d
Days
Class 2
Risk

K143711 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 December 2, 2015 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medovent GmbH devices

FDA 510(k) Submission Details - K143711

510(k) Number K143711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date December 02, 2015
Days to Decision 338 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
190d slower than avg
Panel avg: 148d · This submission: 338d
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 K143711.
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated · Oct 2016
NERBRIDGE
K152967 · Toyobo Co., Ltd. · Jun 2016
Nerve Capping Device
K152684 · Polyganics Innovations BV · Jan 2016
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
NERVE CUFF
K132660 · Cook Biotech Incorporated · Jan 2014