Cleared Traditional

K152769 - FREMAP ELECTRODE

K152769 is an FDA 510(k) clearance for FREMAP ELECTRODE, manufactured by Ad-Tech Medical Instrument Corporation. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K152769 · Ad-Tech Medical Instrument Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
224d
Days
Class 2
Risk

K152769 is an FDA 510(k) clearance for the FREMAP ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corporation (Racine, US). The FDA issued a Cleared decision on May 6, 2016 after a review of 224 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 Ad-Tech Medical Instrument Corporation devices

FDA 510(k) Submission Details - K152769

510(k) Number K152769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date May 06, 2016
Days to Decision 224 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 90d · This submission: 224d
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 Consultant

Quality & Regulatory Associates, LLC
GARY J. SYRING

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETN Stimulator, Nerve

All 79
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