# K990953: Renal Link

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 18, 1999 after 88 days
- Product code: KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K990952: Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures, United States Surgical, A Division of Tyco Healthc (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K061515: Renalsoft (2006), 2 descendants of its own
- K151525: Amia Automated PD System with Sharesource (2015), 1 descendant of its own
- K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (2020), 0 descendants of its own

## Recalls of this device
- Mar 29, 2006 · Not classified · Z-0832-06: 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 m
- Mar 29, 2006 · Not classified · Z-0833-06: 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 m
- Mar 29, 2006 · Not classified · Z-0831-06: 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 m
- Apr 12, 2004 · Not classified · Z-0901-04: 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.
- Apr 12, 2004 · Not classified · Z-0902-04: 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.

## Indications for use
Renal Therapy Clinical Data Management Software is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. Renal Link provides the functions of a data repository and data query/reporting system.

Source page: https://510kreport.com/device/K990953
Methodology: https://510kreport.com/methodology