510(k) · Cleared
ClearedVoyager Peritoneal Dialysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research & Development Corp. · FKX System, Peritoneal, Automatic Delivery
Cleared on Jul 29, 2011 as substantially equivalent to K053512 (Baxter Healthcare Corp, 2006) and 3 other predicates after a 270-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Jul 29, 2011
- Review
- 270 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K923065 (1994). 6 ancestors in all, the oldest K902149 (1990). 3 later devices descend 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 backK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- This deviceK103220 Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011
- Descendant · cites it directly · 2 of its ownK124018 Amia Automated PD SystemDeka Research & Development Corp. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K124018Amia Automated PD SystemDeka Research & Development Corp. · 2013 · cites it directly2descendants
- K151525Amia Automated PD System with SharesourceDeka Research and Development · 2015 · 2 generations on1descendant
- K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…Baxter Healthcare Corporation · 2020 · 3 generations on0descendants
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 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| 0 (this device) | K103220 | Voyager Peritoneal Dialysis System | Deka Research & Development Corp. | 2011 | — |
| +1 | K124018 | Amia Automated PD System | Deka Research & Development Corp. | 2013 | 1 |
| +2 | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | 8 |
| +3 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with… | Baxter Healthcare Corporation | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…ices The Voyager Peritoneal Dialysis (PD) System is substantially equivalent to the HomeChoice Automated Personal Cycler, which was previously cleared under applications K0535 12, K012988, and originally K923065. The Voyager System has the same intended use (with the exception that it is not intended for pe… | 2006 |
| * | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Summary page 1…oyager Peritoneal Dialysis (PD) System is substantially equivalent to the HomeChoice Automated Personal Cycler, which was previously cleared under applications K0535 12, K012988, and originally K923065. The Voyager System has the same intended use (with the exception that it is not intended for pediatric u… | 2001 |
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…is (PD) System is substantially equivalent to the HomeChoice Automated Personal Cycler, which was previously cleared under applications K0535 12, K012988, and originally K923065. The Voyager System has the same intended use (with the exception that it is not intended for pediatric use) and similar technolo… | 1994 |
| * | K043363 | Fresenius Liberty CyclerSummary page 1…gical characteristics. The Voyager device is also substantially equivalent to the Fresenius Liberty Cycler and Disposable Cycler Set which was cleared under application K043363. Device Description The Voyager Peritoneal Dialysis (PD) System is used for automatic control of dialysate solution exchanges in… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124018 | Amia Automated PD System | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K124018 (Deka Research & Development Corp., 2013) has gone furthest, with 2 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 Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103220: Voyager Peritoneal Dialysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103220
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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