Cleared Traditional

K981511 - OTO WIZZARD

K981511 is an FDA 510(k) clearance for OTO WIZZARD, manufactured by Medrx, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K981511 · Medrx, Inc. · Ear, Nose, Throat device
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Jul 1998
Decision
87d
Days
Class 2
Risk

K981511 is an FDA 510(k) clearance for the OTO WIZZARD. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Medrx, Inc. (Seminole, US). The FDA issued a Cleared decision on July 24, 1998 after a review of 87 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 Medrx, Inc. devices

FDA 510(k) Submission Details - K981511

510(k) Number K981511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date July 24, 1998
Days to Decision 87 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
3d faster than avg
Panel avg: 90d · This submission: 87d
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 K981511.
ECHO-SCREEN
K982642 · Fischer-Zoth Audiologic Systems, Inc. · Oct 1998
CCA-220
K982441 · Benson Medical Instruments Co. · Oct 1998
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K982249 · Idem (Int'L Dist. of Electronics For Medicine) · Aug 1998
CCA-200
K981439 · Benson Medical Instruments Co. · Jun 1998
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