Disposable Peritoneal Dialysis Extension

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

510(k) Number

K791722 ↗

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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• What is the disposable peritoneal dialysis extension used for?

  It is used as part of an artificial kidney system to facilitate the instillation of dialysate into the peritoneal cavity for patients with renal failure or toxemic conditions, serving as an administration set in peritoneal dialysis therapy.

• Is the disposable peritoneal dialysis extension intended for single-use or reuse?

  The device is supplied as a disposable, single-use set and is intended for one-time use only in clinical settings, as explicitly stated in the device description to prevent cross-contamination and ensure patient safety.

• What regulatory clearance does the disposable peritoneal dialysis extension have?

  The device has received FDA 510(k) clearance under submission number K791722, which confirms its substantial equivalence to a legally marketed predicate device, and it is classified as a Class II medical device with product code KDJ.