Cleared Traditional

K872042 - PLAYTONE AUDIOMETER

K872042 is an FDA 510(k) clearance for PLAYTONE AUDIOMETER, manufactured by Sensory Aids Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K872042 · Sensory Aids Corp. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 1987
Decision
76d
Days
Class 2
Risk

K872042 is an FDA 510(k) clearance for the PLAYTONE AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Sensory Aids Corp. (Bensenville, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 76 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 Sensory Aids Corp. devices

FDA 510(k) Submission Details - K872042

510(k) Number K872042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date August 11, 1987
Days to Decision 76 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
14d faster than avg
Panel avg: 90d · This submission: 76d
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 131
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K872042.
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · Madsen Electronics (Canada) , Ltd. · Nov 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · American Electromedics Corp. · Jun 1988
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
PHOENIX SYSTEM SEVEN.
K862592 · Nicolet Biomedical Instruments · Sep 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · Miracle-Ear/Dahlberg, Inc. · Mar 1986