Cleared Traditional

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION (K954601) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 15
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K954601.
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K213246 · Medtronic Xomed, Inc. · Mar 2022
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K212355 · Checkpoint Surgical · Aug 2021
StimSite
K200886 · Allotrope Medical, Inc. · Nov 2020
NERVE LOCATER/STIMULATOR
K781569 · Intermedics, Inc. · Dec 1978