Graduated Adapter with Clave

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

510(k) Number

K080007 ↗

FDA product code

EZD

Device class

Class II

Regulation

21 CFR Part 876.5130

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

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See all devices from ICU Medical, Inc. →

• What is the primary purpose of the Graduated Adapter with Clave, and how does it differ from a standard urinary catheter adapter?

  The Graduated Adapter with Clave is designed to facilitate the controlled transfer of fluids into or out of the bladder when connected to a urinary catheter. Unlike standard adapters, it includes a clave connector and graduated markings, allowing for precise measurement of urine drainage. This helps clinicians monitor fluid intake and output more accurately over a 30-day period.

• Is this device intended for reuse, or is it meant to be used only once?

  The Graduated Adapter with Clave is explicitly intended for single-use only. This ensures sterility and reduces the risk of contamination or infection, which is critical for urinary drainage applications.

• How should the device be stored, and what are the key considerations for maintaining its sterility?

  Since the device is supplied sterile, it should be stored in its original, unopened packaging until ready for use. The packaging is designed to preserve sterility, so it should remain intact until the time of use. Avoid exposure to moisture, heat, or direct sunlight, as these factors could compromise sterility.

• What is the maximum duration for which this adapter can be connected to a urinary catheter?

  The device is intended for use with a urinary catheter for a duration not exceeding 30 days. This timeframe aligns with clinical best practices for minimizing infection risks associated with urinary drainage systems.

• What regulatory pathway does this device follow, and what does that mean for its use in clinical settings?

  The Graduated Adapter with Clave follows the FDA 510(k) clearance pathway, specifically under clearance number K080007, and is classified as a Class II medical device under regulation 876.5130. This means it has undergone rigorous review to demonstrate substantial equivalence to a legally marketed device, ensuring it meets safety and performance standards for clinical use in urinary drainage applications.