Cleared Traditional

K121931 - NONDISPOSABLE STIMULATING INSTRUMENTS

K121931 is an FDA 510(k) clearance for NONDISPOSABLE STIMULATING INSTRUMENTS, manufactured by Neurovision Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K121931 · Neurovision Medical Products, Inc. · Ear, Nose, Throat device
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Oct 2012
Decision
109d
Days
Class 2
Risk

K121931 is an FDA 510(k) clearance for the NONDISPOSABLE STIMULATING INSTRUMENTS. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 109 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 Neurovision Medical Products, Inc. devices

FDA 510(k) Submission Details - K121931

510(k) Number K121931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date October 19, 2012
Days to Decision 109 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 89d · This submission: 109d
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 43
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