510(k) · Cleared
ClearedLiberty PDX Cycler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · FKX System, Peritoneal, Automatic Delivery
Cleared on Jul 30, 2014 as substantially equivalent to K123630 (Fresenius Medical Care North America, Design Cente, 2013) after an 89-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Jul 30, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923065 (1994). 6 ancestors in all, the oldest K902149 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 3 generations backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 2 generations backK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- 1 generation backK123630 Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · Recalled
- This deviceK141145 Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014
- Descendant · cites it directly · 4 of its ownK171652 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK181108 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK243371 Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK222318 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK212522 Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K171652Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · cites it directly4descendants
- K181108Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2018 · 2 generations on3descendants
- K243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd. · 2025 · 3 generations on0descendants
- K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on0descendants
- K212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −3 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| −2 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| −1 | K123630 | Fresenius Liberty Cycler | Fresenius Medical Care North America, Design Cente | 2013 | 1 |
| 0 (this device) | K141145 | Liberty PDX Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2014 | — |
| +1 | K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | 2 |
| +2 | K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
| +3 | K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | 2025 | — |
| +3 | K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | 1 |
| +1 | K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K123630 | Fresenius Liberty CyclerSummary page 1…s 11 per 21 CER §876.5630 Product Code/Classification Panel: PKX/GastroenterologyfTjrology 5.3. Legally Marketed Predicate Device Fresenius Liberty Cycler (K 123630) 5.4. Device Description The Liberty PDx Cycler is a software-controlled electromechanical device designed for use in Au… | 2013 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K171652 (Fresenius Medical Care Renal Therapies Group, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K123630.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Liberty PDx Cycler is indicated for acute and chronic peritoneal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141145: Liberty PDX Cycler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141145
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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