Cleared Traditional

K914948 - AM 300 AGC-O

K914948 is an FDA 510(k) clearance for AM 300 AGC-O, 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 107-day FDA review.

K914948 · Electone, Inc. · Ear, Nose, Throat device
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Feb 1992
Decision
107d
Days
Class 1
Risk

K914948 is an FDA 510(k) clearance for the AM 300 AGC-O. 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 February 19, 1992 after a review of 107 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 - K914948

510(k) Number K914948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date February 19, 1992
Days to Decision 107 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
17d slower than avg
Panel avg: 90d · This submission: 107d
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 K914948.
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RIONET HEARING AID HB-23T
K920521 · Authorized Hearing Systems, Inc. · Feb 1992
RIONET HEARING AID HB-23M
K920522 · Authorized Hearing Systems, Inc. · Feb 1992
ELECTONE/PA RECHARGEABLE
K914795 · Electone, Inc. · Feb 1992