Cleared Traditional

K954516 - UNITRON MODEL SOUND F/X II

K954516 is the FDA 510(k) clearance for UNITRON MODEL SOUND F/X II 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 9-day FDA review.

K954516 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Oct 1995
Decision
9d
Days
Class 1
Risk

K954516 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/X II. 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 October 7, 1995 after a review of 9 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 K954516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1995
Decision Date October 07, 1995
Days to Decision 9 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
80d faster than avg
Panel avg: 89d · This submission: 9d
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 K954516.
WIDEX SENSO DIGITAL (PX)
K954526 · Widex Hearing Aid Co., Inc. · Oct 1995
UNITRON MODEL IKON AOHPD
K953727 · Unitron Industries, Inc. · Oct 1995
UNITRON MODEL SOUND F/XD
K953932 · Unitron Industries, Inc. · Oct 1995
MIRACLE - EAR MODEL PBP
K954528 · Miracle-Ear, Inc. · Oct 1995
UNITRON MODEL SOUND F/X
K954430 · Unitron Industries, Inc. · Oct 1995
MAICO PRODIGY CIC SERIES
K954054 · Maico Hearing Instruments, Inc. · Sep 1995