Cleared Traditional

K983352 - ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK

K983352 is an FDA 510(k) clearance for ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK, manufactured by Otodynamics, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K983352 · Otodynamics, Ltd. · Ear, Nose, Throat device
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Dec 1998
Decision
79d
Days
Class 2
Risk

K983352 is an FDA 510(k) clearance for the ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Otodynamics, Ltd. (Crofton, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 79 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 Otodynamics, Ltd. devices

FDA 510(k) Submission Details - K983352

510(k) Number K983352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date December 11, 1998
Days to Decision 79 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
11d faster than avg
Panel avg: 90d · This submission: 79d
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 143
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K983352.
AMPLAID A311 SERIES
K983712 · Amplifon S.P.A. · Jan 1999
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983350 · Otodynamics, Ltd. · Dec 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983351 · Otodynamics, Ltd. · Dec 1998
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K983048 · American Electromedics Corp. · Nov 1998
EARSCAN 3
K982878 · Micro Audiometrics Corp. · Nov 1998
MAICO MA42
K982723 · Bernafon-Maico, Inc. · Oct 1998