Renal Link

• 3 recalls, same reason

  • Terminated Z-0831-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006
  • Terminated Z-0832-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006
  • Terminated Z-0833-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006

  Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

• 2 recalls, same reason

  • Terminated Z-0901-04 FDA Unclassified (pre-2012) ·initiated 12 Apr 2004 ·on shared 510(k) K990953
  • Terminated Z-0902-04 FDA Unclassified (pre-2012) ·initiated 12 Apr 2004 ·on shared 510(k) K990953

  There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K990953 ↗

FDA product code

KPF

Device class

Class II

Regulation

21 CFR Part 876.5630

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

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  GUDID on market

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  FDA 510(k) K220558 Active Cleared 17 Nov 2022 GUDID on market

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  FDA 510(k) K243529 Active Cleared 14 Mar 2025 GUDID on market

See all devices from Baxter Healthcare Corp →

• Is the Renal Link System designed for home use or only for clinical settings like hospitals and dialysis centers?

  The Renal Link System is intended for clinical settings only, such as hospitals and dialysis centers. While it automates peritoneal dialysis exchanges, its reusable design and maintenance requirements make it unsuitable for unsupervised home use without specialized training and infrastructure.

• How is the Renal Link System cleaned and maintained between uses, and is it single-use or reusable?

  The Renal Link System is not single-use—it is a reusable medical device. Between uses, it requires proper cleaning and maintenance as outlined in Baxter Healthcare’s instructions to ensure safety, functionality, and sterility for subsequent patients. This process is critical due to its semi-automatic design for continuous ambulatory or automated peritoneal dialysis.

• What types of peritoneal dialysis (CAPD or APD) is the Renal Link System approved for, and how does it differ in operation?

  The Renal Link System is approved for both continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). CAPD involves manual exchanges throughout the day, while APD automates cycles (e.g., overnight) using the device to deliver and drain dialysate. The system’s semi-automatic functionality supports both modalities by facilitating controlled fluid exchanges in the peritoneal cavity.

• Can the Renal Link System be used in an MRI environment, and if so, what safety considerations apply?

  Yes, the Renal Link System operates within MRI-safe parameters, meaning it can be used in MRI environments without interference or risk to the patient. However, standard MRI safety protocols (e.g., removing metallic components, verifying compatibility with the specific MRI system) should still be followed to ensure no unintended interactions occur during imaging.

• What regulatory pathway was followed for the Renal Link System’s FDA clearance, and which advisory committee reviewed it?

  The Renal Link System received Traditional 510(k) clearance (K990953) under FDA’s substantial equivalence determination, meaning it was deemed comparable to a legally marketed predicate device. The review was conducted by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its classification under FDA regulation 876.5630 for peritoneal dialysis devices.