Cleared Traditional

K912508 - NERVE LOCATOR/MONITOR SYSTEM

K912508 is an FDA 510(k) clearance for NERVE LOCATOR/MONITOR SYSTEM, 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 482-day FDA review.

K912508 · Rln Systems, Inc. · Ear, Nose, Throat device
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Sep 1992
Decision
482d
Days
Class 2
Risk

K912508 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 September 30, 1992 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Rln Systems, Inc. devices

FDA 510(k) Submission Details - K912508

510(k) Number K912508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date September 30, 1992
Days to Decision 482 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
393d slower than avg
Panel avg: 89d · This submission: 482d
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 K912508.
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
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988