Cleared Traditional

K963122 - UNITRON MODEL ICON KR

K963122 is the FDA 510(k) clearance for UNITRON MODEL ICON KR by Unitron Industries, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K963122 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Sep 1996
Decision
25d
Days
Class 1
Risk

K963122 is an FDA 510(k) clearance for the UNITRON MODEL ICON KR. 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 September 6, 1996 after a review of 25 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 Unitron Industries, Inc. devices

Submission Details

510(k) Number K963122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date September 06, 1996
Days to Decision 25 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K963122.
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
K963915 · Telex Communications, Inc. · Nov 1996
RESOUND CC4 PERSONAL HEARING SYSTEM
K964115 · Resound Corp. · Nov 1996
EUROLINE A-675 SERIS
K963519 · Starkey Laboratories, Inc. · Sep 1996
RIONET HB-55AS
K963152 · Authorized Hearing Systems, Inc. · Sep 1996
RIONET HB-55S
K963153 · Authorized Hearing Systems, Inc. · Sep 1996
RIONET HB-54AS
K963154 · Authorized Hearing Systems, Inc. · Sep 1996