Cleared Traditional

NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION (K912508) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K912508.
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