Cleared Traditional

WIDEX MODEL M1 (K853793) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K853793 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Dec 1985
Decision
82d
Days
Class 1
Risk

K853793 is an FDA 510(k) clearance for the WIDEX MODEL M1. 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 December 2, 1985 after a review of 82 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 K853793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date December 02, 1985
Days to Decision 82 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
7d faster than avg
Panel avg: 89d · This submission: 82d
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

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