Cleared Traditional

K950092 - CYPRESS MEDICAL PRODUCTS CATHETER (INSE...

K950092 is an FDA 510(k) clearance for CYPRESS MEDICAL PRODUCTS CATHETER (INSE..., manufactured by Cypress Medical Products, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K950092 · Cypress Medical Products, Ltd. · Gastroenterology & Urology device
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Feb 1995
Decision
48d
Days
Class 2
Risk

K950092 is an FDA 510(k) clearance for the CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 48 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 Cypress Medical Products, Ltd. devices

FDA 510(k) Submission Details - K950092

510(k) Number K950092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 10, 1995
Decision Date February 27, 1995
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 K950092.
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
TOUCHLESS II INTERMITTENT CATHETER
K910653 · C.R. Bard, Inc. · May 1991