Cleared Traditional

K980148 - NEUROSIGN 800

K980148 is an FDA 510(k) clearance for NEUROSIGN 800, manufactured by The Magstim Company , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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

FDA 510(k) Submission Details - K980148

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.

ETN Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K980148.
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999
NIM4
K982595 · Xomed, Inc. · Sep 1998
NEURO PULSE II,III
K971143 · Aaron Medical Industries · Jun 1997
STIMULATING SURGICAL INSTRUMENTS
K934733 · Smith & Nephew Richards, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · R & D Batteries, Inc. · Nov 1993