Cleared Traditional

K951479 - CATHETERIZATION INSERTION PACK UROLOGICAL

K951479 is an FDA 510(k) clearance for CATHETERIZATION INSERTION PACK UROLOGICAL, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K951479 · Trinity Laboratories, Inc. · Gastroenterology & Urology device
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Jun 1995
Decision
77d
Days
Class 2
Risk

K951479 is an FDA 510(k) clearance for the CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on June 15, 1995 after a review of 77 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K951479

510(k) Number K951479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date June 15, 1995
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
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 31
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K951479.
UNIVERSAL DRAINAGE TRAY
K961442 · Customed, Inc. · May 1996
CPR FOLEY CAHTETER KIT
K960214 · Custom Pack Reliability · Apr 1996
CPR URETHRAL CATHETER TRAY
K960215 · Custom Pack Reliability · Apr 1996
UROLOGICAL CATHETER & ACCESSORIES
K951178 · Deroyal Industries, Inc. · Apr 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