Cleared Traditional

K780735 - URINARY CATHETER CARE SET

K780735 is the FDA 510(k) clearance for URINARY CATHETER CARE SET by Shield Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCM) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K780735 · Shield Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
43d
Days
Class 2
Risk

K780735 is an FDA 510(k) clearance for the URINARY CATHETER CARE SET. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Shield Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978 after a review of 43 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 Shield Laboratories, Inc. devices

Submission Details

510(k) Number K780735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1978
Decision Date June 13, 1978
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
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 - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 26
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K780735.
FOLEY CATHETER INSERTION TRAY (10CC)
K901185 · Orion Life Systems, Inc. · Jul 1990
URETHRAL CATHETERIZATION TRAYS
K896212 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
URETHRO CATHETERIZATION TRAY
K780879 · Abco Dealers, Inc. · Jul 1978
URETHRAL TRAY W/CATHETER, 7750
K771103 · Concord Laboratories, Inc. · Jun 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104 · Concord Laboratories, Inc. · Jun 1977
UNIVERSAL TRAY
K770496 · Concord Laboratories, Inc. · Mar 1977