Cleared Traditional

K896212 - URETHRAL CATHETERIZATION TRAYS

K896212 is an FDA 510(k) clearance for URETHRAL CATHETERIZATION TRAYS, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896212 · Westmark, Sterile Packing Systems, Inc. (Sps) · Gastroenterology & Urology device
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Jan 1990
Decision
90d
Days
Class 2
Risk

K896212 is an FDA 510(k) clearance for the URETHRAL CATHETERIZATION TRAYS. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 90 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896212

510(k) Number K896212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 26, 1989
Decision Date January 24, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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 K896212.
URETHRAL CATHETER TRAY (PVC)
K901183 · Orion Life Systems, Inc. · Jul 1990
URETHRAL CATHETER TRAY (LATEX)
K901184 · Orion Life Systems, Inc. · Jul 1990
FOLEY CATHETER INSERTION TRAY (10CC)
K901185 · Orion Life Systems, Inc. · Jul 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