Cleared Traditional

K780675 - STERILE 100% SILICONE FOLEY CATHETER

K780675 is the FDA 510(k) clearance for STERILE 100% SILICONE FOLEY CATHETER by Medline Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K780675 · Medline Industries, Inc. · Gastroenterology & Urology device
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May 1978
Decision
15d
Days
Class 2
Risk

K780675 is an FDA 510(k) clearance for the STERILE 100% SILICONE FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1978 after a review of 15 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K780675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date May 09, 1978
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K780675.
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 CLOSED SYSTEM
K780676 · Medline Industries, Inc. · May 1978
CATHETER, URETHERAL
K770814 · C.R. Bard, Inc. · Oct 1977
CATHETERIZATION SYS. URINARY DRAINAGE
K771779 · Medical Devices, Inc. · Oct 1977