Cleared Traditional

K970974 - WILLIAMS SOUND

K970974 is an FDA 510(k) clearance for WILLIAMS SOUND, manufactured by Williams Sound, LLC. The device is a Class 2 Ear, Nose, Throat device with product code LZI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K970974 · Williams Sound, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
46d
Days
Class 2
Risk

K970974 is an FDA 510(k) clearance for the WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER. Classified as Device, Assistive Listening (product code LZI), Class II - Special Controls.

Submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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 Williams Sound, LLC devices

FDA 510(k) Submission Details - K970974

510(k) Number K970974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date May 02, 1997
Days to Decision 46 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZI Device Classification - Class 2, Special Controls

Product Code LZI Device, Assistive Listening
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.