Cleared Traditional

K780124 - CATHETERIZATION PROCED. TRAY

K780124 is the FDA 510(k) clearance for CATHETERIZATION PROCED. TRAY by Walpak Co.. It is a Class 2 Gastroenterology & Urology device (product code FCM) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K780124 · Walpak Co. · Gastroenterology & Urology device

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Feb 1978

Decision

28d

Days

Class 2

Risk

K780124 is an FDA 510(k) clearance for the CATHETERIZATION PROCED. TRAY, URETHRAL. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Walpak Co. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978 after a review of 28 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 Walpak Co. devices

Submission Details

510(k) Number	K780124 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 24, 1978
Decision Date	February 21, 1978
Days to Decision	28 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

102d faster than avg

Panel avg: 130d · This submission: 28d

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 K780124.

FOLEY CATHETER INSERTION TRAY (10CC)

K901185 · Orion Life Systems, Inc. · Jul 1990

URETHRAL CATHETERIZATION TRAYS

K896212 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 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

UNIVERSAL TRAY

K770496 · Concord Laboratories, Inc. · Mar 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K780124

Walpak Co.

Mchenry, IL · US

Regulatory profile

11 submissions 10 cleared

91% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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