Cleared Traditional

K970519 - UNITRON MODEL SOUND F/X PROGRAMMABLE IT...

K970519 is the FDA 510(k) clearance for UNITRON MODEL SOUND F/X PROGRAMMABLE IT... 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 72-day FDA review.

K970519 · Unitron Industries, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
72d
Days
Class 1
Risk

K970519 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE). 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 April 24, 1997 after a review of 72 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 K970519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date April 24, 1997
Days to Decision 72 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
17d faster than avg
Panel avg: 89d · This submission: 72d
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 K970519.
RIONET HB-79P
K971693 · Authorized Hearing Systems, Inc. · Jun 1997
UNITRON MODEL SOUND F/X CIC
K970692 · Unitron Industries, Inc. · May 1997
PRECISE IMPRESSION KIT
K970952 · Starkey Laboratories, Inc. · May 1997
AUDALLION II HEARING SYSTEM
K970215 · Resound Corp. · Mar 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · Miracle-Ear, Inc. · Mar 1997
WIDEX SENSO DIGITAL (CIC)
K970904 · Widex Hearing Aid Co., Inc. · Mar 1997