510(k) · Cleared
Recalled · Class II · 2018Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471R and 5C8310R
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 30, 2011 as substantially equivalent to K053512 (Baxter Healthcare Corp, 2006) and 2 other predicates after a 177-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled 11 times.
- Decided
- Mar 30, 2011
- Review
- 177 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923065 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 2 generations backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 1 generation backK053512 Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis…Baxter Healthcare Corp · 2006 · Recalled
- This deviceK102936 Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal…Baxter Healthcare Corp · 2011
- Descendant · cites it directly · 0 of its ownK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…Baxter Healthcare Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −2 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| −1 | K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models… | Baxter Healthcare Corp | 2006 | 3 |
| 0 (this device) | K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System… | Baxter Healthcare Corp | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and…Summary page 1…l Cycler COMMON NAME Automated Peritoneal Dialysis (APD) Cycler CLASSIFICATION NAME Peritoneal dialysis system and accessories per 21 CFR 876.5630 PREDICATE DEVICE K0535 12 HomeChoiee/HomeChoice PRO Automated Personal Cycler K012988 HomeChoice/HomeChoice PRO Automated Perso… | 2006 |
| * | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Summary page 1…CATION NAME Peritoneal dialysis system and accessories per 21 CFR 876.5630 PREDICATE DEVICE K0535 12 HomeChoiee/HomeChoice PRO Automated Personal Cycler K012988 HomeChoice/HomeChoice PRO Automated Personal Cycler K923065 HomeChoice/HomeChoice PRO Automated Pers… | 2001 |
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…PREDICATE DEVICE K0535 12 HomeChoiee/HomeChoice PRO Automated Personal Cycler K012988 HomeChoice/HomeChoice PRO Automated Personal Cycler K923065 HomeChoice/HomeChoice PRO Automated Personal Cycler… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2018 | Class II | Z-0030-2020 | Mixed-up of materials/components | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may… |
| Jul 5, 2017 | Class II | Z-3041-2017 | Use error | Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis… |
| Jul 5, 2017 | Class II | Z-3040-2017 | Use error | Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis… |
| Dec 16, 2016 | Class II | Z-1056-2017 | Device Design | Customer complaints received for the presence of leaks |
| Jun 29, 2015 | Class III | Z-0291-2016 | Device Design | Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the… |
| Dec 8, 2014 | Class II | Z-1039-2015 | Device Design | Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage. |
| Oct 21, 2014 | Class II | Z-1031-2015 | Nonconforming Material/Component | The keypad buttons on HomeChoice devices may be activated without the operator pressing them. |
| Oct 6, 2014 | Class II | Z-0939-2015 | Labeling design | There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems. |
| Apr 3, 2014 | Class II | Z-1245-2015 | Error in labeling | Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with… |
| Oct 16, 2013 | Class II | Z-1292-2015 | Process design | The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and… |
| Oct 7, 2013 | Class II | Z-2609-2016 | Labeling design | In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K201867 (Baxter Healthcare Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K053512.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The HomeChoicelHomeChoice Pro 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/K102936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102936: Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471R and 5C8310R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102936
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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