Cleared Traditional

K980505 - HORTMANN AMDIS-OAE OAE ANALYZER

K980505 is an FDA 510(k) clearance for HORTMANN AMDIS-OAE OAE ANALYZER, manufactured by Hortmann AG. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K980505 · Hortmann AG · Ear, Nose, Throat device
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Apr 1998
Decision
57d
Days
Class 2
Risk

K980505 is an FDA 510(k) clearance for the HORTMANN AMDIS-OAE OAE ANALYZER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Hortmann AG (Dripping Springs, US). The FDA issued a Cleared decision on April 7, 1998 after a review of 57 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 Hortmann AG devices

FDA 510(k) Submission Details - K980505

510(k) Number K980505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date April 07, 1998
Days to Decision 57 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
33d faster than avg
Panel avg: 90d · This submission: 57d
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 K980505.
CUB DIS II DPOAE MEASUREMENT SYSTEM
K981460 · Mimosa Acoustics, Inc. · May 1998
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K981327 · Idem (Int'L Dist. of Electronics For Medicine) · May 1998
MAICO MA53
K981142 · Bernafon-Maico, Inc. · Apr 1998
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
K980533 · Etymotic Research · Mar 1998
SIBELMED AC50D
K973377 · Trutone · Mar 1998
GSI 70 AUDIOPATH SCREENER
K974237 · Grason-Stadler, Inc. · Feb 1998