510(k) · Cleared
Recalled · Class II · 2025Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · FKX System, Peritoneal, Automatic Delivery
Cleared on Nov 19, 2020 as substantially equivalent to K102936 (Baxter Healthcare Corp, 2011) and 1 other predicate after a 135-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 2 times.
- Decided
- Nov 19, 2020
- Review
- 135 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K923065 (1994). 12 ancestors in all, the oldest K902149 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 5 generations backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 4 generations backK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- 3 generations backK103220 Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011
- 2 generations backK124018 Amia Automated PD SystemDeka Research & Development Corp. · 2013 · Recalled
- 1 generation backK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015 · Recalled
- This deviceK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −5 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| −4 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| −3 | K103220 | Voyager Peritoneal Dialysis System | Deka Research & Development Corp. | 2011 | — |
| −2 | K124018 | Amia Automated PD System | Deka Research & Development Corp. | 2013 | 1 |
| −1 | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | 8 |
| 0 (this device) | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with… | Baxter Healthcare Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 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 FKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FKX device
- #1 K243371 Byonyks X-1 APD Cycler; Byonyks Automated PD…score 11.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model…Summary page 5…lly equivalent to the HomeChoice/HomeChoice PRO Automated Peritoneal Dialysis personal cyclers, which were previously cleared under 510(k) premarket notification K102936. The Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is substantially equivalent to the S… | 2011 |
| * | K151525 | Amia Automated PD System with SharesourceSummary page 5…stantially equivalent to the Sharesource Connectivity Platform for Use with the AMIA APD System, which was previously cleared under 510(k) premarket notification K151525. DESCRIPTION OF THE DEVICE: The Homechoice Claria APD System (Claria) is intended for automatic control of dialysis… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class II | Z-0409-2026 | Software design | Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their… |
| Feb 22, 2023 | Class II | Z-1316-2023 | Process design | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 10 of the 12 ancestors have a recall of any class.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FKX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FKX
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FKX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKX
3,128in 2025
MAUDE reports naming product code FKX, 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 | 147 |
| 2008 | 0 | — | 0 | 702 |
| 2009 | 0 | — | 0 | 340 |
| 2010 | 0 | — | 5 | 4,966 |
| 2011 | 2 | — | 2 | 11,304 |
| 2012 | 0 | — | 2 | 18,034 |
| 2013 | 2 | — | 1 | 22,093 |
| 2014 | 1 | — | 4 | 28,289 |
| 2015 | 1 | — | 2 | 24,663 |
| 2016 | 0 | — | 1 | 6,137 |
| 2017 | 1 | — | 0 | 3,127 |
| 2018 | 2 | — | 3 | 5,927 |
| 2019 | 0 | — | 0 | 5,972 |
| 2020 | 1 | — | 1 | 4,598 |
| 2021 | 0 | — | 0 | 5,076 |
| 2022 | 4 | 209 | 0 | 4,503 |
| 2023 | 0 | — | 2 | 3,913 |
| 2024 | 0 | — | 0 | 3,771 |
| 2025 | 2 | — | 1 | 3,128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities. The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis…
Read the full statement (106 words)
Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities.
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system 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/K201867 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201867
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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