510(k) · Cleared
Recalled · 2011Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FKX System, Peritoneal, Automatic Delivery
Cleared on Feb 16, 2006 as substantially equivalent to K923065 (Baxter Healthcare Corp, 1994) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 16, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923065 (1994). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 1 generation backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- This deviceK053512 Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis…Baxter Healthcare Corp · 2006
- Descendant · cites it directly · 3 of its ownK103220 Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011
- Descendant · 2 generations on · 2 of its ownK124018 Amia Automated PD SystemDeka Research & Development Corp. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK102936 Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal…Baxter Healthcare Corp · 2011 · 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 5 of 5 · See all- K103220Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011 · cites it directly3descendants
- K124018Amia Automated PD SystemDeka Research & Development Corp. · 2013 · 2 generations on2descendants
- K151525Amia Automated PD System with SharesourceDeka Research and Development · 2015 · 3 generations on1descendant
- K102936Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model…Baxter Healthcare Corp · 2011 · cites it directly1descendant
- K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…Baxter Healthcare Corporation · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −1 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| 0 (this device) | K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models… | Baxter Healthcare Corp | 2006 | — |
| +1 | K103220 | Voyager Peritoneal Dialysis System | Deka Research & Development Corp. | 2011 | — |
| +2 | K124018 | Amia Automated PD System | Deka Research & Development Corp. | 2013 | 1 |
| +3 | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | 8 |
| +1 | K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System… | Baxter Healthcare Corp | 2011 | 11 |
| +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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 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 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 11.1 · 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 |
|---|---|---|---|
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…876.5630 Equivalent Predicate: HomeChoice Automated Personal Cycler Peritoneal Dialysis System (K923065 and K01 2988) Device Description: The HomeChoice Automated Personal Cycler, version 8.9… | 1994 |
| * | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Summary page 1…876.5630 Equivalent Predicate: HomeChoice Automated Personal Cycler Peritoneal Dialysis System (K923065 and K01 2988) Device Description: The HomeChoice Automated Personal Cycler, version 8.9 soft… | 2001 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2011 | Not classified | Z-2129-2011 | Other | Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of bums, electrocution, fire, or injury to persons… |
| Jan 8, 2010 | Not classified | Z-0799-2010 | Labeling design | Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death. |
| Jan 8, 2010 | Not classified | Z-0800-2010 | Labeling design | Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 7.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K103220 (Deka Research & Development Corp., 2011) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K923065.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The HomeChoice Automated Personal Cycler Peritoneal Dialysis System is intended for
automatic control of dialysate solution exchanges in the treatment of pediatric and adult
renal failure patients undergoing peritoneal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053512: Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053512
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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