Cleared Traditional

K200759 - NIM Vital, Nerve Integrity Monitor

K200759 is an FDA 510(k) clearance for NIM Vital, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K200759 · Medtronic Xomed, Inc. · Neurology device
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Oct 2020
Decision
218d
Days
Class 2
Risk

K200759 is an FDA 510(k) clearance for the NIM Vital, Nerve Integrity Monitor. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 28, 2020 after a review of 218 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K200759

510(k) Number K200759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2020
Decision Date October 28, 2020
Days to Decision 218 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
70d slower than avg
Panel avg: 148d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 94
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K200759.
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
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K182542 · Safeop Surgical, Inc. · Feb 2019
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
K170677 · Neurovision Medical Product, Inc. · Apr 2017
MEP Monitor
K162873 · Tonica Elektronik A/S · Mar 2017