Cleared Traditional

K952454 - EXPANDER WITH ACTIVE TONE CONTROL

K952454 is an FDA 510(k) clearance for EXPANDER WITH ACTIVE TONE CONTROL, manufactured by Argosy Electronics. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K952454 · Argosy Electronics · Ear, Nose, Throat device
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Jun 1995
Decision
27d
Days
Class 1
Risk

K952454 is an FDA 510(k) clearance for the EXPANDER WITH ACTIVE TONE CONTROL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Argosy Electronics (Eden Prairie, US). The FDA issued a Cleared decision on June 21, 1995 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 Argosy Electronics devices

FDA 510(k) Submission Details - K952454

510(k) Number K952454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date June 21, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K952454.
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828 · Siemens Hearing Instruments, Inc. · Jun 1995
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OTOSONIC (OSI) CF 10-K, 10-D
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WIDEX MODEL LOGO 32 (L32)
K952229 · Widex Hearing Aid Co., Inc. · Jun 1995
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
K952228 · Resound Corp. · Jun 1995
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263 · Siemens Hearing Instruments, Inc. · Jun 1995