Peritoneal Dialysis Cycler Set

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K813069 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K861251 Active Cleared 17 Apr 1986

• Cycler W/5 or 10 Hr. Fill/Dwell Timer

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  FDA 510(k) K800496 Active Cleared 21 Jul 1980

• Set, Administration, Manual, Dialysis

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  FDA 510(k) K780957 Active Cleared 6 Jul 1978

• Ccpd Cycler Set W/5 Pronged Connector

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  FDA 510(k) K822545 Active Cleared 13 Oct 1982

• Amp Mark IV Infusion Pump

  Class II

  FDA 510(k) K811918 Active Cleared 20 Jul 1981

• Ampercide Disinfectant Accessory to -

  Class II

  FDA 510(k) K830881 Active Cleared 2 Jun 1983

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• What is the Peritoneal Dialysis Cycler Set used for?

  The Peritoneal Dialysis Cycler Set is designed to function as an automated system for peritoneal dialysis. It cycles dialysate through a patient’s peritoneal cavity to remove waste products and excess fluids, effectively mimicking the function of a kidney. This is particularly useful for patients with renal failure or toxemic conditions who require regular fluid and toxin removal.

• Is the Peritoneal Dialysis Cycler Set single-use or reusable?

  The Peritoneal Dialysis Cycler Set is supplied as a single-use, disposable device. This design ensures sterility and reduces the risk of contamination or cross-infection between patients. After use, the set should be discarded according to manufacturer guidelines.

• How is sterility maintained for this device?

  The Peritoneal Dialysis Cycler Set is sterile as supplied, meaning it is packaged and sealed to prevent microbial contamination before use. Proper storage and handling—such as keeping the set in its original, unopened packaging and avoiding exposure to moisture or physical damage—are critical to preserving sterility. Always follow the manufacturer’s instructions for storage and preparation.

• Can this device be used with any peritoneal access device?

  The Peritoneal Dialysis Cycler Set is designed for compatibility with standard peritoneal access devices. However, compatibility may depend on the specific access device used, its condition, and proper connection techniques. Always verify compatibility with your healthcare provider or refer to the manufacturer’s instructions to ensure safe and effective use.

• What regulatory clearance does this device hold?

  The Peritoneal Dialysis Cycler Set holds FDA 510(k) clearance under the classification of Substantially Equivalent (SESE), with the decision date of November 16, 1981 (K-number: K813069). This clearance indicates that the device meets regulatory standards for safety and effectiveness as determined by the FDA. For detailed regulatory information, refer to the FDA’s device database.