Cleared Traditional

K933291 - MAICO BTE MODEL RD-111 AND ITE MODEL RD...

K933291 is the FDA 510(k) clearance for MAICO BTE MODEL RD-111 AND ITE MODEL RD... by Maico Hearing Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K933291 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
48d
Days
Class 1
Risk

K933291 is an FDA 510(k) clearance for the MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Maico Hearing Instruments, Inc. devices

Submission Details

510(k) Number K933291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date August 23, 1993
Days to Decision 48 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
41d faster than avg
Panel avg: 89d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
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 - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K933291.
BOSCH EUROSTAR
K933988 · Starkey Laboratories, Inc. · Oct 1993
RESOLUTION ITC HEARING AID
K933989 · Starkey Laboratories, Inc. · Oct 1993
AS-90
K923006 · Qualitone · Sep 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579 · Telex Communications, Inc. · Aug 1993
WIDEX MODEL LOGO 12 (L12)
K933640 · Widex Hearing Aid Co., Inc. · Aug 1993
WIDEX MODEL LOGO 6 (L6)
K933643 · Widex Hearing Aid Co., Inc. · Aug 1993