510(k) · Cleared
Recalled · 2007Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469
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 Dec 5, 2001 as substantially equivalent to K923065 (Baxter Healthcare Corp, 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 17 later devices descend from it. It has been recalled 9 times.
- Decided
- Dec 5, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923065 (1994). 17 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- This deviceK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001
- Descendant · cites it directly · 13 of its ownK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK123630 Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · Recalled
- Descendant · 3 generations on · 5 of its ownK141145 Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014
- Descendant · cites it directly · 5 of its ownK053512 Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis…Baxter Healthcare Corp · 2006 · Recalled
- Descendant · 3 generations on · 4 of its ownK171652 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K043363Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · cites it directly13descendants
- K123630Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · 2 generations on6descendants
- K141145Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014 · 3 generations on5descendants
- K053512Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and…Baxter Healthcare Corp · 2006 · cites it directly5descendants
- K171652Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| 0 (this device) | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | — |
| +1 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| +2 | K123630 | Fresenius Liberty Cycler | Fresenius Medical Care North America, Design Cente | 2013 | 1 |
| +3 | K141145 | Liberty PDX Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2014 | — |
| +1 | K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models… | Baxter Healthcare Corp | 2006 | 3 |
| +3 | K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…Peritoneal dialysis system and Accessories (per 21CFR 876.5630) Substantially equivalent devices HomeChoice® Personal Cycler Peritoneal Dialysis System [510(k) number K923065] Description of the device The HomeChoice® Personal Cycler Peritoneal Dialysis System provides automatic control of dialysate s… | 1994 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043363 | Fresenius Liberty Cycler | 2005 | 13 |
| K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and… | 2006 | 5 |
| K103220 | Voyager Peritoneal Dialysis System | 2011 | 3 |
| K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model… | 2011 | 1 |
| K031676 | Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q… | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2007 | Not classified | Z-0947-2008 | Device Design | Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may… |
| Sep 12, 2005 | Not classified | Z-0139-06 | Other | The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis… |
| Jun 21, 2005 | Not classified | Z-1019-05 | Other | The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard. |
| Dec 23, 2004 | Not classified | Z-0397-05 | Other | A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products. |
| Nov 1, 2004 | Not classified | Z-0189-05 | Other | The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user. |
| Nov 1, 2004 | Not classified | Z-0188-05 | Other | The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user. |
| May 24, 2004 | Not classified | Z-1013-04 | Other | A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at… |
| Dec 23, 2002 | Not classified | Z-0565-03 | Other | Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy |
| Dec 23, 2002 | Not classified | Z-0564-03 | Other | Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012988 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012988
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026