Cleared Traditional

K982595 - NIM4

K982595 is an FDA 510(k) clearance for NIM4, manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K982595 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
39d
Days
Class 2
Risk

K982595 is an FDA 510(k) clearance for the NIM4. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xomed, Inc. devices

FDA 510(k) Submission Details - K982595

510(k) Number K982595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date September 04, 1998
Days to Decision 39 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 90d · This submission: 39d
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 72
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K982595.
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
K991583 · The Magstim Company , Ltd. · May 1999
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K980148 · The Magstim Company , Ltd. · Aug 1998
URO MED NERVE STIMULATOR
K970971 · Uromed Corp. · Oct 1997
NEURO PULSE II,III
K971143 · Aaron Medical Industries · Jun 1997