Cleared Traditional

K874018 - NEUROPROBE

K874018 is an FDA 510(k) clearance for NEUROPROBE, manufactured by Inovx, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K874018 · Inovx, Inc. · Ear, Nose, Throat device
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Jun 1988
Decision
243d
Days
Class 2
Risk

K874018 is an FDA 510(k) clearance for the NEUROPROBE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Inovx, Inc. (Los Altos, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 243 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 - K874018

510(k) Number K874018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1987
Decision Date June 01, 1988
Days to Decision 243 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
153d slower than avg
Panel avg: 90d · This submission: 243d
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 92
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K874018.
BRACKMANN EMG MONITORING SYSTEM
K895838 · Wr Medical Electronics Co. · Mar 1990
HEMOSTAT/STIMULATOR PROBE
K895676 · Rln Systems, Inc. · Dec 1989
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988
NICOLET DISPOSABLE PRASS PROBE
K873964 · Nicolet Biomedical Instruments · Nov 1987
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
K874018 · NEUROPROBE
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