Cleared Traditional

K920092 - AUDIOTONE MODEL A97

K920092 is the FDA 510(k) clearance for AUDIOTONE MODEL A97 by Miracle-Ear, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K920092 · Miracle-Ear, Inc. · General Hospital
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Jan 1992
Decision
20d
Days
Class 1
Risk

K920092 is an FDA 510(k) clearance for the AUDIOTONE MODEL A97. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Miracle-Ear, Inc. (Golden Valley, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital 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 Miracle-Ear, Inc. devices

Submission Details

510(k) Number K920092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date January 28, 1992
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYY Latex Patient Examination Glove

All 206
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K920092.
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · Siam Sempermed Corp., Ltd. · Feb 1993
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · Wembley Rubber Products (M) Sdn Bhd · Aug 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991
PATIENT EXAMINATION GLOVES
K905551 · Johnson & Johnson Medical, Inc. · Jan 1991