Cleared Traditional

K970555 - IL0292 DP ECHOPORT

K970555 is an FDA 510(k) clearance for IL0292 DP ECHOPORT, manufactured by Smith. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K970555 · Smith · Ear, Nose, Throat device
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Mar 1997
Decision
32d
Days
Class 2
Risk

K970555 is an FDA 510(k) clearance for the IL0292 DP ECHOPORT. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith devices

FDA 510(k) Submission Details - K970555

510(k) Number K970555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1997
Decision Date March 17, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 90d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K970555.
MAICO MA52
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RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
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SMARTOAE
K964426 · Intelligent Hearing Systems · Feb 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · Otodynamics, Ltd. · Jan 1997
PORTAREM-3000, PFS-6000
K964340 · Starkey Laboratories, Inc. · Jan 1997