Cleared Traditional

K854517 - NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K854517 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Dec 1985
Decision
20d
Days
Class 1
Risk

K854517 is an FDA 510(k) clearance for the NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET. Classified as Clamp, Line (product code FKK), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on December 2, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K854517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 02, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FKK Clamp, Line
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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.