Cleared Traditional

K895838 - BRACKMANN EMG MONITORING SYSTEM

K895838 is an FDA 510(k) clearance for BRACKMANN EMG MONITORING SYSTEM, manufactured by Wr Medical Electronics Co.. The device is a Class 2 Ear, Nose, Throat device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K895838

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
86d slower than avg
Panel avg: 90d · This submission: 176d
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 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K895838.
AXOSTIM NERVE STIMULATOR, MODIFICATION
K905035 · Singer Medical Products, Inc. · Apr 1991
NERVE LOCATOR/STIMULATOR
K905045 · Aaron Medical Industries · Mar 1991
DENTEC 4000
K894930 · Dentec, Inc. · Mar 1990
HEMOSTAT/STIMULATOR PROBE
K895676 · Rln Systems, Inc. · Dec 1989
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
NEUROPROBE
K874018 · Inovx, Inc. · Jun 1988
K895838 · BRACKMANN EMG MONITORING SYSTEM
Download PDF Wr Medical Electronic…