Cleared Traditional

K760048 - TRAY

K760048 is the FDA 510(k) clearance for TRAY by M-C Ind., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCM) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K760048 · M-C Ind., Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
259d
Days
Class 2
Risk

K760048 is an FDA 510(k) clearance for the TRAY, URETHRAL CATHETERIZATION. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by M-C Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 259 days - an extended review 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: 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 M-C Ind., Inc. devices

Submission Details

510(k) Number K760048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1976
Decision Date March 01, 1977
Days to Decision 259 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 130d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K760048.
URETHRAL TRAY W/CATHETER, 7750
K771103 · Concord Laboratories, Inc. · Jun 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104 · Concord Laboratories, Inc. · Jun 1977
UNIVERSAL TRAY
K770496 · Concord Laboratories, Inc. · Mar 1977
TRAY, CATHETERIZATION W/O CATHETER
K760127 · Concord Laboratories, Inc. · Oct 1976
TRAY, CATHETERIZATION W/ CATHETER
K760128 · Concord Laboratories, Inc. · Oct 1976