Cleared Traditional

K851857 - UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER

K851857 is an FDA 510(k) clearance for UROLOGICAL CATHETER & ACCESSORIES FOLEY..., manufactured by Sheridan Catheter Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K851857 · Sheridan Catheter Corp. · Gastroenterology & Urology device
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Jul 1985
Decision
80d
Days
Class 2
Risk

K851857 is an FDA 510(k) clearance for the UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 80 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 Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K851857

510(k) Number K851857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date July 15, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 131d · This submission: 80d
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 147
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K851857.
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
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VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · Van-Tec, Inc. · 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