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Foley Catheterization Tray

FDA 510(k)

Class II (US FDA 510(k))

510(k) K942177

by Customed, Inc.

Identifiers

510(k) Number
K942177 FDA 510(k)
FDA Product Code
FCM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Foley Catheterization Tray is a sterile urethral catheterization kit, designed for use in the placement of Foley catheters. It combines a catheter with associated accessories in a single organized tray to facilitate aseptic procedures in clinical settings such as urology and gastroenterology.

This tray is supplied as a reusable stainless steel instrument tray with a strap handle, available in dimensions of 9 x 4 x 2 or 17 x 4 x 2-1/8 inches. It is intended for single-use applications and must be handled under sterile conditions. The device holds catheters such as silicone-elastomer coated latex Foley catheters (e.g., 18 Fr with 10 mL antireflux towers) and accompanying drainage bags. Authorized under FDA 510(k) clearance K942177, it falls under regulation 876.5130 and is classified as a Class II medical device.

Frequently asked questions

What clinical specialties is this Foley Catheterization Tray primarily intended for, and why is that relevant to my practice?

This tray is designed for use in urology and gastroenterology procedures, as indicated by its advisory committee classification (GU) and medical specialty description. This makes it particularly relevant for clinicians in those fields who frequently perform urethral catheterization, ensuring compatibility with standard workflows in those specialties.

Is the tray itself reusable, or is it meant for single-use only? How does this affect its handling?

The Foley Catheterization Tray itself is reusable, constructed from stainless steel with a strap handle, but it is intended for single-use applications when assembled with sterile components like catheters and drainage bags. This means the tray must be cleaned and sterilized between uses, while the included catheters and accessories are disposable and used only once per patient.

What sizes are available for the tray, and how might this impact my choice based on the procedure or patient?

The tray is available in two dimensions: 9 x 4 x 2 inches or 17 x 4 x 2-1/8 inches. The larger size may be preferable for procedures requiring more accessories or when working in confined spaces, while the smaller size could be better for compact setups or pediatric cases where less space is needed.

Are the catheters included in the tray sterile, and what precautions should I take when using this kit?

Yes, the Foley Catheterization Tray is described as a sterile urethral catheterization kit, meaning all components—including the catheters and drainage bags—are pre-sterilized for single-use. To maintain sterility, handle the tray under aseptic conditions, avoid opening it prematurely, and follow standard sterile technique during catheterization to prevent contamination.

What type of catheters does this tray typically include, and can I mix and match sizes or types?

The tray is designed to hold silicone-elastomer coated latex Foley catheters, such as an 18 Fr with 10 mL antireflux towers, though the exact specifications may vary by lot. While the tray is structured for these types, customization is not explicitly supported—users should verify compatibility with the manufacturer if mixing sizes or materials, as the tray’s design is optimized for the listed catheter types.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FOLEY CATHETERIZATION TRAY (K942177) — FDA 510(k) | Innolitics, Amazon.com: Catheter Tray, FOLEY CATHETERIZATION TRAY 510(k) K942177 - FDA.report, SureStep™ Foley Tray System - BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Customed, Inc.

Sources (1)

  • FDA 510(k) K942177 24 fields · synced Sep 19, 2026