Cleared Traditional

K933644 - WIDEX MODEL LOGO 8 (L8)

K933644 is the FDA 510(k) clearance for WIDEX MODEL LOGO 8 (L8) by Widex Hearing Aid Co., Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K933644 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
27d
Days
Class 1
Risk

K933644 is an FDA 510(k) clearance for the WIDEX MODEL LOGO 8 (L8). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 27 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 Widex Hearing Aid Co., Inc. devices

Submission Details

510(k) Number K933644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date August 23, 1993
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
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 612
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K933644.
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
BELTONE PRIMA 2000
K932703 · Beltone Electronics Corp. · Aug 1993
OTICON MF
K932670 · Oticon Corp. · Aug 1993
GOLD ASP MODULE, ITE
K933036 · Electone, Inc. · Aug 1993