Cleared Traditional

ROUND WINDOW E-CATH (K973740) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973740 · Neuro-Biometrix, Inc. · Ear, Nose, Throat device
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Mar 1998
Decision
173d
Days
Class 2
Risk

K973740 is an FDA 510(k) clearance for the ROUND WINDOW E-CATH. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Neuro-Biometrix, Inc. (Englewood, US). The FDA issued a Cleared decision on March 23, 1998 after a review of 173 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 Neuro-Biometrix, Inc. devices

Submission Details

510(k) Number K973740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1997
Decision Date March 23, 1998
Days to Decision 173 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
84d slower than avg
Panel avg: 89d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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.