Cleared Traditional

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K980148) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980148 · The Magstim Company , Ltd. · Ear, Nose, Throat device
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Aug 1998
Decision
202d
Days
Class 2
Risk

K980148 is an FDA 510(k) clearance for the NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by The Magstim Company , Ltd. (Carmarthenshire, GB). The FDA issued a Cleared decision on August 5, 1998 after a review of 202 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all The Magstim Company , Ltd. devices

Submission Details

510(k) Number K980148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1998
Decision Date August 05, 1998
Days to Decision 202 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 89d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 17
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K980148.
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K212355 · Checkpoint Surgical · Aug 2021
StimSite
K200886 · Allotrope Medical, Inc. · Nov 2020
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984
NERVE LOCATER/STIMULATOR
K781569 · Intermedics, Inc. · Dec 1978