Cleared Traditional

K851684 - UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER

K851684 is an FDA 510(k) clearance for UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER, manufactured by Urotec Systems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K851684 · Urotec Systems Corp. · Gastroenterology & Urology device
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Jul 1985
Decision
70d
Days
Class 2
Risk

K851684 is an FDA 510(k) clearance for the UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Urotec Systems Corp. (Pittsburgh, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Urotec Systems Corp. devices

FDA 510(k) Submission Details - K851684

510(k) Number K851684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date July 02, 1985
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.

Regulatory Peers - KOD Catheter, Urological

All 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K851684.
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · Van-Tec, Inc. · Jul 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · Sheridan Catheter Corp. · Jul 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
URETEROSCOPY CATHETER
K850335 · Inmed Corp. · Mar 1985
NORTA SILICONIZED LATEX BALLOON CATH.
K842420 · Beiersdorf, Inc. · Nov 1984