Cleared Traditional

K933400 - KENDALL CURITY 100% SILICONE FOLEY CATH...

K933400 is an FDA 510(k) clearance for KENDALL CURITY 100% SILICONE FOLEY CATH..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K933400 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
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Nov 1993
Decision
126d
Days
Class 2
Risk

K933400 is an FDA 510(k) clearance for the KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 15, 1993 after a review of 126 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K933400

510(k) Number K933400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date November 15, 1993
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 130d · This submission: 126d
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 141
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K933400.
NOPROFILE OLBERT CATHETER SYSTEM
K945061 · Meadox Surgimed, Inc. · Mar 1995
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · Cook Urological, Inc. · Dec 1993
ONIK-COHEN ACCESS SET
K930608 · Cook Urological, Inc. · Jul 1993
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992