Cleared Traditional

K843246 - HEARING AID, UNITRON UE12-PPL

K843246 is an FDA 510(k) clearance for HEARING AID, manufactured by Unitron Industries, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K843246 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Jan 1985
Decision
156d
Days
Class 1
Risk

K843246 is an FDA 510(k) clearance for the HEARING AID, UNITRON UE12-PPL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Unitron Industries, Inc. (Port Huron, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 156 days - an extended review 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: 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 Unitron Industries, Inc. devices

FDA 510(k) Submission Details - K843246

510(k) Number K843246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date January 23, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 90d · This submission: 156d
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 K843246.
HEARING AID 365
K850243 · Telex Communications, Inc. · Mar 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · Oticon Corp. · Mar 1985
EARETTE HEARING AID OTICON E32U
K850763 · Oticon Corp. · Mar 1985
HEARING AID, UNITRON UE12-PP
K843245 · Unitron Industries, Inc. · Jan 1985
MODEL 363C HEARING AID
K844648 · Telex Communications, Inc. · Jan 1985
ULTRA & ULTRA MINATURE
K843789 · Qualitone · Dec 1984