Cleared Traditional

LYELL SOUND (K954972) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K954972 · Venture Management Corp. · Gastroenterology & Urology device
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Jan 1996
Decision
89d
Days
Class 1
Risk

K954972 is an FDA 510(k) clearance for the LYELL SOUND. Classified as Sound, Metal, Interconnected (product code FBS), Class I - General Controls.

Submitted by Venture Management Corp. (Palm Harbor, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4590 - the FDA gastroenterology and urology 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 Venture Management Corp. devices

Submission Details

510(k) Number K954972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date January 24, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FBS Sound, Metal, Interconnected
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4590
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.