Cleared Traditional

K950390 - URETHRAL CATHETERIZATION TRAY

K950390 is an FDA 510(k) clearance for URETHRAL CATHETERIZATION TRAY, manufactured by Medcare Custom Packaging, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K950390 · Medcare Custom Packaging, Inc. · Gastroenterology & Urology device
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May 1995
Decision
118d
Days
Class 2
Risk

K950390 is an FDA 510(k) clearance for the URETHRAL CATHETERIZATION TRAY. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (East Swanzey, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcare Custom Packaging, Inc. devices

FDA 510(k) Submission Details - K950390

510(k) Number K950390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date May 30, 1995
Days to Decision 118 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 130d · This submission: 118d
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 26
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K950390.
SELF CATH SET/SAFETY CATH
K983010 · Rusch Intl. · Feb 1999
UNIVERSAL DRAINAGE TRAY
K961442 · Customed, Inc. · May 1996
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · Trinity Laboratories, Inc. · Jun 1995
UROLOGICAL CATHETER & ACCESSORIES
K951178 · Deroyal Industries, Inc. · Apr 1995
FOLEY CATHETERIZATION TRAY
K942177 · Customed, Inc. · Sep 1994
MON-A-THERM FOLEY KIT
K923538 · Mallinckrodt Medical · May 1993