480 High-Flow Ultrafiltration Control Dialysate

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K880459 ↗

FDA Product Code

FKP

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Drake Willock Central Dialysate Delivery System

  Class II

  FDA 510(k) K862304 Active Cleared 9 Sep 1986

• 8810 Pump-Pump Single Needle Device

  Class II

  FDA 510(k) K873279 Active Cleared 23 Oct 1987

• Ultrx(Tm) 850 Artificial Kidney

  Class II

  FDA 510(k) K884353 Active Cleared 8 Dec 1988

• Cd Home Dialyservice Hemodialysis Tray

  Class II

  FDA 510(k) K925654 Active Cleared 30 Mar 1994

• Drake Willock Reverse Osmosis Water Treatment Syst

  Class II

  FDA 510(k) K894106 Active Cleared 8 Nov 1989

• Wurtz Choley Clip (Tm)

  Class I

  FDA 510(k) K901520 Active Cleared 26 Jun 1990

See all devices from Cd Medical, Inc. →

• What specific clinical applications does the 480 High-Flow Ultrafiltration Control Dialysate support during dialysis therapy?

  This device is designed to regulate and monitor critical parameters—such as dialysate flow, temperature, conductivity, and pressure—during hemodialysis. It ensures precise ultrafiltration control, which is essential for managing fluid removal in patients with acute or chronic kidney failure. The system is specifically part of a single-patient-use dialysate delivery system, making it suitable for renal replacement therapy in clinical settings like dialysis centers.

• Is the 480 High-Flow Ultrafiltration Control Dialysate intended for reuse, or is it meant for single-patient use?

  The device is explicitly labeled as a single-patient-use dialysate delivery system, meaning it is not designed for reuse. While the data does not explicitly state sterility, the single-patient-use designation implies that disposable components are intended for one-time use per patient to maintain safety and hygiene standards.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The 480 High-Flow Ultrafiltration Control Dialysate received FDA 510(k) clearance (K880459) under the Traditional 510(k) review pathway, with a decision date of April 13, 1988. This means the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device, allowing it to enter the market without requiring a new clinical trial. Clinically, this clearance confirms the device meets FDA safety and effectiveness standards for its intended use in hemodialysis.

• How is the device classified under FDA regulations, and what does that classification imply for its oversight?

  This device is classified as a Class II medical device under 21 CFR 876.5820, which means it is subject to special controls—such as performance standards, labeling requirements, and post-market surveillance—to ensure its safety and effectiveness. While Class II devices generally pose moderate risk, the FDA imposes additional scrutiny compared to Class I devices, ensuring rigorous validation of its performance in ultrafiltration control during dialysis.