Centry 2 Ultrafiltration Control Kit, #018762-002

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

510(k) Number

K881062 ↗

FDA Product Code

FJB

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Centry 2 Ultrafiltration Control Kit in peritoneal dialysis procedures?

  The Centry 2 Ultrafiltration Control Kit (#018762-002) is designed to monitor and regulate ultrafiltration during peritoneal dialysis. It acts as a detector and dialysate level control device to ensure precise fluid management, helping maintain safe and effective therapy by regulating the dialysate volume during the procedure.

• Is the Centry 2 Ultrafiltration Control Kit intended for single-use or repeated use?

  The kit is explicitly labeled as a single-use component, meaning it is not meant for reuse. This designation aligns with its non-sterile supply, as single-use devices are typically not sterilized for repeated applications to avoid contamination risks.

• How was the regulatory clearance for this device obtained, and what classification does it fall under?

  The Centry 2 Ultrafiltration Control Kit was cleared via a Traditional 510(k) pathway with a Substantially Equivalent (SESE) determination, meaning it was found to be comparable to a legally marketed predicate device. It is classified as a Class II medical device under FDA regulations, subject to special controls, and was originally submitted in 1988.

• What type of regulatory oversight or advisory committee was involved in the clearance of this device?

  The clearance process for this device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, as indicated in the submission details. This committee provides expert input on devices related to gastrointestinal and urological applications, including peritoneal dialysis systems.

• Why is the kit described as non-sterile, and what does this mean for clinical use?

  The kit is labeled non-sterile, meaning it is not pre-sterilized for direct patient contact. In clinical use, this implies that the kit must be handled in a manner that prevents contamination before integration into a sterile peritoneal dialysis system. Sterilization would typically occur within the broader dialysis circuit where the kit is deployed.