Cleared Traditional

K905045 - NERVE LOCATOR/STIMULATOR

K905045 is the FDA 510(k) clearance for NERVE LOCATOR/STIMULATOR by Aaron Medical Industries. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K905045 · Aaron Medical Industries · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
127d
Days
Class 2
Risk

K905045 is an FDA 510(k) clearance for the NERVE LOCATOR/STIMULATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 127 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 Aaron Medical Industries devices

Submission Details

510(k) Number K905045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date March 15, 1991
Days to Decision 127 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 89d · This submission: 127d
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 37
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K905045.
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
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984