# K061515: Renalsoft

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 11, 2006 after 102 days
- Product code: KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990953 (1999). 1 ancestor in all.
2 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)
- K990953: Renal Link, Baxter Healthcare Corp (1999) Summary page 1.

## Most influential descendants
- 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
- Nov 14, 2007 · Not classified · Z-0527-2008: 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 
- Nov 14, 2007 · Not classified · Z-0528-2008: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K061515
Methodology: https://510kreport.com/methodology