Cleared Traditional

K942177 - FOLEY CATHETERIZATION TRAY

K942177 is an FDA 510(k) clearance for FOLEY CATHETERIZATION TRAY, manufactured by Customed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K942177 · Customed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
127d
Days
Class 2
Risk

K942177 is an FDA 510(k) clearance for the FOLEY CATHETERIZATION TRAY. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 127 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 Customed, Inc. devices

FDA 510(k) Submission Details - K942177

510(k) Number K942177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date September 08, 1994
Days to Decision 127 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
3d faster than avg
Panel avg: 130d · This submission: 127d
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 K942177.
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
MON-A-THERM FOLEY KIT
K923538 · Mallinckrodt Medical · May 1993
TOUCHLESS II INTERMITTENT CATHETER
K910653 · C.R. Bard, Inc. · May 1991
FOLEY CATHETER INSERTION TRAY (30CC)
K901180 · Orion Life Systems, Inc. · Jul 1990