Cleared Traditional

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (K913721) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913721 · Fiberoptic Sensor Technlogies, Inc. · Gastroenterology & Urology device
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Oct 1991
Decision
49d
Days
Class 2
Risk

K913721 is an FDA 510(k) clearance for the FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Fiberoptic Sensor Technlogies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Fiberoptic Sensor Technlogies, Inc. devices

Submission Details

510(k) Number K913721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date October 08, 1991
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 Gastroenterology & Urology devices follow this clearance model.