510(k) · Cleared
Recalled · Class II · 2021Fresenius Liberty Cycler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · FKX System, Peritoneal, Automatic Delivery
Cleared on Mar 31, 2005 as substantially equivalent to K902149 (Fresenius/Delmed, Inc., 1990) and 3 other predicates after a 114-day review. Its family tree reaches back 2 generations to 1994. 13 later devices descend from it. It has been recalled 9 times.
- Decided
- Mar 31, 2005
- Review
- 114 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 9
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923065 (1994). 4 ancestors in all, the oldest K902149 (1990). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 1 generation backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- This deviceK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005
- Descendant · cites it directly · 6 of its ownK123630 Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · Recalled
- Descendant · 2 generations on · 5 of its ownK141145 Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK171652 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK181108 Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2018
- Descendant · cites it directly · 3 of its ownK103220 Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K123630Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013 · cites it directly6descendants
- K141145Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014 · 2 generations on5descendants
- K171652Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2017 · 2 generations on4descendants
- K181108Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC · 2018 · 3 generations on3descendants
- K103220Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −1 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| 0 (this device) | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | — |
| +1 | K123630 | Fresenius Liberty Cycler | Fresenius Medical Care North America, Design Cente | 2013 | 1 |
| +2 | 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 |
| +3 | K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
| +1 | K103220 | Voyager Peritoneal Dialysis System | Deka Research & Development Corp. | 2011 | — |
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 |
|---|---|---|
| 2011 | 1 | 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), 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 |
|---|---|---|---|
| * | K902149 | Fresenius/Delmed 90/2 Peritoneal Dialysis SystemSummary page 1…Peritoneal, Automatic Delivery C. Predicate Device Name: The predicate devices for the Fresenius Liberty Cycler are the following: * Fresenius 90/2 Cycler - #K902149 (10/30/90); * Baxter HomeChoice Pro -#K012988 (12/5/01) and #K923065 (3/4/94); * Fresenius PD' l~rard Cycler-#K002892 (… | 1990 |
| * | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Summary page 1…e Name: The predicate devices for the Fresenius Liberty Cycler are the following: * Fresenius 90/2 Cycler - #K902149 (10/30/90); * Baxter HomeChoice Pro -#K012988 (12/5/01) and #K923065 (3/4/94); * Fresenius PD' l~rard Cycler-#K002892 (4/5/01).… | 2001 |
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…te devices for the Fresenius Liberty Cycler are the following: * Fresenius 90/2 Cycler - #K902149 (10/30/90); * Baxter HomeChoice Pro -#K012988 (12/5/01) and #K923065 (3/4/94); * Fresenius PD' l~rard Cycler-#K002892 (4/5/01).… | 1994 |
| * | K002892 | Frsenius PD Iqcard CyclerSummary page 1…llowing: * Fresenius 90/2 Cycler - #K902149 (10/30/90); * Baxter HomeChoice Pro -#K012988 (12/5/01) and #K923065 (3/4/94); * Fresenius PD' l~rard Cycler-#K002892 (4/5/01). 000065… | 2001 |
What descends from it? (13)
See all 134 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2021 | Class II | Z-2085-2021 | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Dec 15, 2015 | Class II | Z-0693-2016 | Device Design | The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased… |
| Oct 14, 2013 | Class II | Z-0148-2014 | Device Design | Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis |
| Jun 3, 2013 | Class II | Z-1674-2013 | Unknown/Undetermined by firm | Cassette may leak during set up or during peritoneal dialysis treatment |
| Oct 12, 2012 | Class II | Z-0799-2013 | Process control | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. |
| Mar 30, 2012 | Not classified | Z-1448-2012 | Software design | Increased risk of intraperitoneal volume (IIPV), referred to as Overfill |
| Sep 3, 2010 | Not classified | Z-0104-2011 | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. |
| Sep 3, 2010 | Not classified | Z-0105-2011 | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. |
| Sep 3, 2010 | Not classified | Z-0103-2011 | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. |
The 5 latest of 9 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 11 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123630 (Fresenius Medical Care North America, Design Cente, 2013) has gone furthest, with 6 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 | — |
What is it indicated for?
The Fresenius Liberty Cycler is intended for acute and chronic peritoneal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043363: Fresenius Liberty Cycler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043363
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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