Cleared Traditional

K895838 - BRACKMANN EMG MONITORING SYSTEM

K895838 is the FDA 510(k) clearance for BRACKMANN EMG MONITORING SYSTEM by Wr Medical Electronics Co.. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K895838 · Wr Medical Electronics Co. · Ear, Nose, Throat device
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Mar 1990
Decision
176d
Days
Class 2
Risk

K895838 is an FDA 510(k) clearance for the BRACKMANN EMG MONITORING SYSTEM. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Wr Medical Electronics Co. (Stillwater, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 176 days - an extended review cycle.

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 Wr Medical Electronics Co. devices

Submission Details

510(k) Number K895838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date March 27, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 89d · This submission: 176d
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 33
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K895838.
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
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984