Urethral Catheterization Tray

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K842866 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Celestin Pulsion Esophogeal Prosthesis

  Class II

  FDA 510(k) K813169 Active Cleared 3 Dec 1981

• Deaver T-Drain & Cattel T-Drain

  Class II

  FDA 510(k) K841034 Active Cleared 13 Apr 1984

• Blakemore Tube

  Class II

  FDA 510(k) K841038 Active Cleared 13 Apr 1984

• Rectal Balloon Catheters

  Class II

  FDA 510(k) K841036 Active Cleared 13 Apr 1984

• Cole Tube-Latex

  Class II

  FDA 510(k) K840973 Active Cleared 30 Mar 1984

• Nasopharyngeal Airways

  Class I

  FDA 510(k) K841093 Active Cleared 23 Mar 1984

See all devices from Inmed Corp. →

• What clinical settings is this Urethral Catheterization Tray designed for, and what does it include to support aseptic procedures?

  The Urethral Catheterization Tray is designed for use in hospitals, outpatient clinics, and physician offices. It is a sterile, single-use tray that includes essential components like catheters, lubricants, drapes, gloves, swabs, and specimen containers. These items are organized to streamline workflow and maintain aseptic conditions during urethral catheterization procedures.

• Is this tray reusable, or is it intended for single-use only? What does that mean for preparation and handling?

  This tray is explicitly designed for single-use only, meaning it is sterile out of the package and requires no additional preparation beyond standard sterile field protocols. Since it is not intended for reuse, it must be discarded after a single procedure to maintain sterility and infection control.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical practice?

  The Urethral Catheterization Tray received FDA 510(k) clearance (K842866) under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device. This means it has been reviewed by the FDA as meeting safety and effectiveness standards for its intended use in urethral catheterization procedures. The clearance does not imply any specific clinical indication but confirms compliance with regulatory requirements.

• Does this tray come in multiple catheter sizes, and if so, how would a clinician determine which size to use?

  While the regulatory filings reference multiple catheter sizes and configurations, the exact dimensions are not detailed in the provided data. Clinicians should refer to the tray’s packaging or accompanying instructions for specific size options and select the appropriate catheter based on patient anatomy and clinical guidelines. The tray’s design ensures compatibility with standard urethral catheterization practices.

• How should this tray be stored, and what precautions should be taken to maintain its sterility before use?

  The tray is supplied sterile and should be stored in its original, unopened packaging to preserve sterility. It must be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the tray should be used immediately, and any unused components should be discarded to prevent contamination. Follow standard sterile field protocols when preparing for use.