Cleared Traditional

K903143 - OTOSCREENER-I AND OTO-SCREEN-I-P

K903143 is an FDA 510(k) clearance for OTOSCREENER-I AND OTO-SCREEN-I-P, manufactured by Handtronix, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K903143 · Handtronix, Inc. · Ear, Nose, Throat device
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Sep 1990
Decision
63d
Days
Class 2
Risk

K903143 is an FDA 510(k) clearance for the OTOSCREENER-I AND OTO-SCREEN-I-P. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Handtronix, Inc. (Sandy, US). The FDA issued a Cleared decision on September 19, 1990 after a review of 63 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 Handtronix, Inc. devices

FDA 510(k) Submission Details - K903143

510(k) Number K903143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date September 19, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 89d · This submission: 63d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K903143.
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · Resound Corp. · Sep 1991
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · Qualitone · Oct 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · Starkey Laboratories, Inc. · Aug 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · Maico Hearing Instruments, Inc. · Jan 1990
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · Maico Hearing Instruments, Inc. · Oct 1989