Cleared Traditional

K823788 - MECON I

K823788 is an FDA 510(k) clearance for MECON I, manufactured by Mecon Labs. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K823788 · Mecon Labs · Ear, Nose, Throat device
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Mar 1983
Decision
103d
Days
Class 1
Risk

K823788 is an FDA 510(k) clearance for the MECON I. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Mecon Labs (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 103 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 Mecon Labs devices

FDA 510(k) Submission Details - K823788

510(k) Number K823788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date March 29, 1983
Days to Decision 103 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
14d slower than avg
Panel avg: 89d · This submission: 103d
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 K823788.
RIONET HEARING AID -AND/OR RION
K831721 · Rion Acoustic Instruments, Inc. · Jul 1983
WIDEX HEARING AID #G2H & G2T
K830465 · Widex Hearing Aid Co., Inc. · May 1983
MODEL 343D HEARING AID
K831197 · Telex Communications, Inc. · May 1983
RIONET HEARING AID
K830236 · Rion Acoustic Instruments, Inc. · Mar 1983
800 BLUE
K830303 · Electone, Inc. · Mar 1983
HEARING AID, #UE7-D
K830402 · Unitron Industries, Inc. · Mar 1983