Cleared Traditional

K951178 - UROLOGICAL CATHETER & ACCESSORIES

K951178 is an FDA 510(k) clearance for UROLOGICAL CATHETER & ACCESSORIES, manufactured by Deroyal Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K951178 · Deroyal Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
37d
Days
Class 2
Risk

K951178 is an FDA 510(k) clearance for the UROLOGICAL CATHETER & ACCESSORIES. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 21, 1995 after a review of 37 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K951178

510(k) Number K951178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1995
Decision Date April 21, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 131d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCM Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K951178.
CPR URETHRAL CATHETER TRAY
K960215 · Custom Pack Reliability · Apr 1996
NHMC FOLEY CATHETERIZATION TRAY
K960566 · National Healthcare Mfg. Corp. · Feb 1996
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · Trinity Laboratories, Inc. · Jun 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
K950092 · Cypress Medical Products, Ltd. · Feb 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
K950109 · Cypress Medical Products, Ltd. · Feb 1995
FOLEY CATHETERIZATION TRAY
K942177 · Customed, Inc. · Sep 1994