510(k) · Cleared
Recalled · 2007Renalsoft
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 Sep 11, 2006 as substantially equivalent to K990953 (Baxter Healthcare Corp, 1999) after a 102-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 11, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- KPF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990953 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK990953 Renal LinkBaxter Healthcare Corp · 1999 · Recalled
- This deviceK061515 RenalsoftBaxter Healthcare Corp · 2006
- Descendant · cites it directly · 1 of its ownK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990953 | Renal Link | Baxter Healthcare Corp | 1999 | 5 |
| 0 (this device) | K061515 | Renalsoft | Baxter Healthcare Corp | 2006 | — |
| +1 | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | 8 |
| +2 | 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 |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990953 | Renal LinkSummary page 1…876.5620, and Peritoneal dialysis system and accessories per 21 CER 876.5630 Equivalent Predicate: Renal Link (K990953) Device Description: RenalSoft is designed specifically for nephrology and of… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151525 | Amia Automated PD System with Sharesource | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2007 | Not classified | Z-0527-2008 | Software design | Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld… |
| Nov 14, 2007 | Not classified | Z-0528-2008 | Software design | Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K151525 (Deka Research and Development, 2015) has gone furthest, with 1 descendant 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 Soft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. RenalSoft provides the functions of a data repository and data query/reporting system. This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061515: Renalsoft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061515
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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