Cleared Traditional

K973740 - ROUND WINDOW E-CATH

K973740 is an FDA 510(k) clearance for ROUND WINDOW E-CATH, manufactured by Neuro-Biometrix, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K973740 · Neuro-Biometrix, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K973740

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.

ETD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ETD Tube, Tympanostomy

All 69
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K973740.
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999
EXMOOR MYRINGOTOMY KIT
K980828 · Exmoor Plastics , Ltd. · Oct 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · Exmoor Plastics , Ltd. · May 1998
SHAH PERMAVENT
K974007 · Exmoor Plastics , Ltd. · Dec 1997
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996