Cleared Traditional

K954601 - NERVE LOCATOR/MONITOR SYSTEM MODIFICATION

K954601 is an FDA 510(k) clearance for NERVE LOCATOR/MONITOR SYSTEM MODIFICATION, manufactured by Rln Systems, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K954601 · Rln Systems, Inc. · Ear, Nose, Throat device
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Dec 1995
Decision
101d
Days
Class 2
Risk

K954601 is an FDA 510(k) clearance for the NERVE LOCATOR/MONITOR SYSTEM MODIFICATION. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Rln Systems, Inc. (Jefferson City, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 101 days - within the typical 510(k) review window.

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 Rln Systems, Inc. devices

FDA 510(k) Submission Details - K954601

510(k) Number K954601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date December 22, 1995
Days to Decision 101 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
12d slower than avg
Panel avg: 89d · This submission: 101d
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 42
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K954601.
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
NERVE LOCATOR/STIMULATOR
K905045 · Aaron Medical Industries · Mar 1991