Cleared Traditional

K790728 - TOUCHLESS TM FOLEY CATHETER KIT

K790728 is an FDA 510(k) clearance for TOUCHLESS TM FOLEY CATHETER KIT, manufactured by Diamed Division Ill. Tool Works, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K790728 · Diamed Division Ill. Tool Works, Inc. · Gastroenterology & Urology device
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Jun 1979
Decision
49d
Days
Class 2
Risk

K790728 is an FDA 510(k) clearance for the TOUCHLESS TM FOLEY CATHETER KIT. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Diamed Division Ill. Tool Works, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 49 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 Diamed Division Ill. Tool Works, Inc. devices

FDA 510(k) Submission Details - K790728

510(k) Number K790728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1979
Decision Date June 01, 1979
Days to Decision 49 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
82d faster than avg
Panel avg: 131d · This submission: 49d
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 160
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K790728.
CONPHAR FEMALE CATHETER-STERILE
K791244 · Conphar, Inc. · Sep 1979
CONPHAR NELATON CATHETER-STERILE
K791264 · Conphar, Inc. · Aug 1979
UNIVERSAL FOLEY CATHETER TRAY
K791332 · Abco Dealers, Inc. · Aug 1979
STERILE 100% SILICONE FOLEY CATHETER
K780675 · Medline Industries, Inc. · May 1978
STERILE CLOSED SYSTEM
K780676 · Medline Industries, Inc. · May 1978
CATHETER, URETHERAL
K770814 · C.R. Bard, Inc. · Oct 1977