Cleared Traditional

K954430 - UNITRON MODEL SOUND F/X

K954430 is the FDA 510(k) clearance for UNITRON MODEL SOUND F/X 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 14-day FDA review.

K954430 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Oct 1995
Decision
14d
Days
Class 1
Risk

K954430 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/X. 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 6, 1995 after a review of 14 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 K954430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1995
Decision Date October 06, 1995
Days to Decision 14 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
75d faster than avg
Panel avg: 89d · This submission: 14d
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 K954430.
UNITRON MODEL SOUND F/XD
K953932 · Unitron Industries, Inc. · Oct 1995
UNITRON MODEL SOUND F/X II
K954516 · Unitron Industries, Inc. · Oct 1995
MIRACLE - EAR MODEL PBP
K954528 · Miracle-Ear, Inc. · Oct 1995
MAICO PRODIGY CIC SERIES
K954054 · Maico Hearing Instruments, Inc. · Sep 1995
3M MODEL 8295
K954067 · 3M Company · Sep 1995
PHONAK 9900 CIC
K953921 · Phonak, Inc. · Sep 1995