Cleared Traditional

K860484 - CURITY & KENGUARD SILICONE COATED FOLEY...

K860484 is an FDA 510(k) clearance for CURITY & KENGUARD SILICONE COATED FOLEY..., manufactured by The Kendal Co.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K860484 · The Kendal Co. · Gastroenterology & Urology device
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Mar 1986
Decision
29d
Days
Class 2
Risk

K860484 is an FDA 510(k) clearance for the CURITY & KENGUARD SILICONE COATED FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 29 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 The Kendal Co. devices

FDA 510(k) Submission Details - K860484

510(k) Number K860484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1986
Decision Date March 11, 1986
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 136
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K860484.
VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.
K860337 · Van-Tec, Inc. · Mar 1986
ANGIOMED URETER DIATION SETS
K855076 · Angiomed U.S., Inc. · Mar 1986
ANGIOMED EXCHANGE DRAINAGE CATHETER SETS
K855143 · Angiomed U.S., Inc. · Mar 1986
ANGIOMED RENAL DILATION SET
K855140 · Angiomed U.S., Inc. · Feb 1986
ANGIOMED HARZMANN DISCS
K855077 · Angiomed U.S., Inc. · Jan 1986
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985