Cleared Traditional

K852084 - KENDALL CURITY 100% SILICONE FOLEY CATH...

K852084 is an FDA 510(k) clearance for KENDALL CURITY 100% SILICONE FOLEY CATH..., 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 130-day FDA review.

K852084 · The Kendal Co. · Gastroenterology & Urology device
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Sep 1985
Decision
130d
Days
Class 2
Risk

K852084 is an FDA 510(k) clearance for the KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP. 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 September 20, 1985 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Kendal Co. devices

FDA 510(k) Submission Details - K852084

510(k) Number K852084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date September 20, 1985
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
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 K852084.
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986
ANGIOMED RENAL DILATION SET
K855140 · Angiomed U.S., Inc. · Feb 1986
ANGIOMED HARZMANN DISCS
K855077 · Angiomed U.S., Inc. · Jan 1986
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · American Pharmaseal Div. Ahsc · Sep 1985
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · Van-Tec, Inc. · Jul 1985