510(k) · Cleared
ClearedByonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byonyks Pvt, Ltd. · FKX System, Peritoneal, Automatic Delivery
Cleared on May 16, 2025 as substantially equivalent to K181108 (Fresenius Medical Care Renal Therapies Group, LLC, 2018) after a 198-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- May 16, 2025
- Review
- 198 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K923065 (1994). 9 ancestors in all, the oldest K902149 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 6 generations backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 5 generations backK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- 4 generations backK123630 Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · Recalled
- 3 generations backK141145 Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014
- 2 generations backK171652 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · Recalled
- 1 generation backK181108 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2018
- This deviceK243371 Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −6 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| −5 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| −4 | 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 | — |
| −2 | K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | 2 |
| −1 | K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
| 0 (this device) | K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 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 K250523 Archimedes Pro Automated Peritoneal Dialysis…score 10.1 · 1 generation · 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 |
|---|---|---|---|
| * | K181108 | Fresenius Liberty Select CyclerSummary page 5…c Delivery Associated Product Code KDJ 5 Predicate Device The legally marketed predicate device is the Fresenius Liberty Select Cycler cleared under K181108. The Fresenius Multiple Tubing Segment (MTS) Set with stay•safe® PIN Connectors (K173651) is a reference device with respect to b… | 2018 |
| † | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 6 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181108.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Byonyks X-1 APD Cycler is indicated for acute and chronic 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/K243371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243371: Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243371
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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