510(k) · Cleared
Recalled · 2006Renal Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Cleared on Jun 18, 1999 after an 88-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 18, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- KPF
- Recalls
- 5
- Predicates
- 1
3 later devices descend from it, 1 citing it directly.
- This deviceK990953 Renal LinkBaxter Healthcare Corp · 1999
- Descendant · cites it directly · 2 of its ownK061515 RenalsoftBaxter Healthcare Corp · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K061515RenalsoftBaxter Healthcare Corp · 2006 · cites it directly2descendants
- K151525Amia Automated PD System with SharesourceDeka Research and Development · 2015 · 2 generations on1descendant
- K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…Baxter Healthcare Corporation · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990953 | Renal Link | Baxter Healthcare Corp | 1999 | — |
| +1 | K061515 | Renalsoft | Baxter Healthcare Corp | 2006 | 2 |
| +2 | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | 8 |
| +3 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with… | Baxter Healthcare Corporation | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K990952 | FDA’s K990952 is Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061515 | Renalsoft | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2006 | Not classified | Z-0832-06 | Other | 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. |
| Mar 29, 2006 | Not classified | Z-0833-06 | Other | 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. |
| Mar 29, 2006 | Not classified | Z-0831-06 | Other | 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. |
| Apr 12, 2004 | Not classified | Z-0901-04 | Other | 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 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061515 (Baxter Healthcare Corp, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KPF devicesKPF System, Dialysate Delivery, Semi-Automatic, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPF
FDA has decided no KPF device since 2007.
Median 510(k) review, days · KPF
Too few KPF 510(k)s in any year since 2007 to give a median.
Recalls per year · KPF
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPF
1in 2018
MAUDE reports naming product code KPF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990953: Renal Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990953
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026