Cleared Traditional

K843226 - EVOKED RESPONSE ELECTRICAL STIMULATOR

K843226 is an FDA 510(k) clearance for EVOKED RESPONSE ELECTRICAL STIMULATOR, manufactured by Nucleus, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K843226 · Nucleus, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
278d
Days
Class 2
Risk

K843226 is an FDA 510(k) clearance for the EVOKED RESPONSE ELECTRICAL STIMULATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nucleus, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 278 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 Nucleus, Ltd. devices

FDA 510(k) Submission Details - K843226

510(k) Number K843226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1984
Decision Date May 21, 1985
Days to Decision 278 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
189d slower than avg
Panel avg: 89d · This submission: 278d
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 K843226.
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984
NEUROTRAC
K831715 · Hdc Corp. · Jul 1983
NERVE LOCATER/STIMULATOR
K781569 · Intermedics, Inc. · Dec 1978