Cleared Traditional

K974242 - ARGOSY PROGRAMMABLE ONQUE

K974242 is an FDA 510(k) clearance for ARGOSY PROGRAMMABLE ONQUE, 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 69-day FDA review.

K974242 · Argosy Electronics · Ear, Nose, Throat device
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Jan 1998
Decision
69d
Days
Class 1
Risk

K974242 is an FDA 510(k) clearance for the ARGOSY PROGRAMMABLE ONQUE. 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 January 20, 1998 after a review of 69 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 - K974242

510(k) Number K974242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date January 20, 1998
Days to Decision 69 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
21d faster than avg
Panel avg: 90d · This submission: 69d
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 K974242.
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · Siemens Hearing Instruments, Inc. · Apr 2001
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518 · Sonic Innovations, Inc. · Mar 1999
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751 · General Hearing Instruments, Inc. · Mar 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880 · Sonix Technologies, Inc. · Jan 1998
OPUS 2 - CANAL SERIES (ITC)
K974069 · Bernafon-Maico, Inc. · Dec 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K974152 · Bernafon-Maico, Inc. · Dec 1997