Cleared Traditional

K951642 - GOLD CD ULTRA MINI CANAL - MODULE

K951642 is an FDA 510(k) clearance for GOLD CD ULTRA MINI CANAL - MODULE, manufactured by Electone, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K951642 · Electone, Inc. · Ear, Nose, Throat device
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Jul 1995
Decision
92d
Days
Class 1
Risk

K951642 is an FDA 510(k) clearance for the GOLD CD ULTRA MINI CANAL - MODULE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Electone, Inc. devices

FDA 510(k) Submission Details - K951642

510(k) Number K951642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date July 11, 1995
Days to Decision 92 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
2d slower than avg
Panel avg: 90d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K951642.
HEARING AID
K952658 · Philips Hearing Instruments Co. · Jul 1995
PERSONAL PROGRAMMER 2000
K952940 · Siemens Hearing Instruments, Inc. · Jul 1995
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K953266 · Resound Corp. · Jul 1995
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
K952450 · Argosy Electronics · Jul 1995
CLASS D LINEAR WITH ACTIVE TONE CONTROL
K952451 · Argosy Electronics · Jul 1995
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
K952452 · Argosy Electronics · Jul 1995