Cleared Traditional

K974340 - UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE

K974340 is an FDA 510(k) clearance for UNITRON MODEL SOUND F/XP PROGRAMMABLE M..., 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 24-day FDA review.

K974340 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Dec 1997
Decision
24d
Days
Class 1
Risk

K974340 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE. 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 December 12, 1997 after a review of 24 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

FDA 510(k) Submission Details - K974340

510(k) Number K974340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date December 12, 1997
Days to Decision 24 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 90d · This submission: 24d
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 K974340.
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K974257 · Resound Corp. · Dec 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338 · Unitron Industries, Inc. · Dec 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339 · Unitron Industries, Inc. · Dec 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K973927 · Hyunjae Corp. · Dec 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
K973861 · Magnatone Hearing Aid Corp. · Nov 1997
MAGNATONE / STERLING/ ST
K973665 · Magnatone Hearing Aid Corp. · Nov 1997