510(k) · Cleared
Recalled · Class II · 2012Baxter Personal Cycler Autommated Peritoneal Dial
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 Mar 4, 1994 after a 617-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 4, 1994
- Review
- 617 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 4
- Predicates
- 0
18 later devices descend from it, 6 citing it directly.
- This deviceK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994
- Descendant · cites it directly · 17 of its ownK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K012988Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Baxter Healthcare Corp · 2001 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | — |
| +1 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471… | 2001 | 17 |
| 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 |
|---|---|---|---|---|
| Jul 6, 2012 | Class II | Z-2132-2012 | Employee error | Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette. |
| Nov 20, 2007 | Not classified | Z-0946-2008 | 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… |
| Jun 21, 2005 | Not classified | Z-1018-05 | 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 electric shock hazard. |
| May 24, 2004 | Not classified | Z-1012-04 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012988 (Baxter Healthcare Corp, 2001) has gone furthest, with 17 descendants of its own.
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 | — |
https://510kreport.com/device/K923065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K923065: Baxter Personal Cycler Autommated Peritoneal Dial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923065
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026