Cleared Traditional

NEUROSIGN 100 IMPEDANCE METER (K945799) - FDA 510(k) Clearance

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

K945799 · The Magstim Company , Ltd. · Ear, Nose, Throat device
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Jun 1995
Decision
186d
Days
Class 2
Risk

K945799 is an FDA 510(k) clearance for the NEUROSIGN 100 IMPEDANCE METER. 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 June 2, 1995 after a review of 186 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 K945799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date June 02, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 89d · This submission: 186d
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 K945799.
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