510(k) · Cleared
Recalled · Class II · 2015Fresenius Liberty Cycler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America, Design Cente · FKX System, Peritoneal, Automatic Delivery
Cleared on Sep 9, 2013 as substantially equivalent to K043363 (Fresenius Medical Care North America, 2005) after a 290-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2013
- Review
- 290 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923065 (1994). 5 ancestors in all, the oldest K902149 (1990). 6 later devices descend from it, 2 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 deviceK123630 Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 2013
- Descendant · cites it directly · 5 of its ownK141145 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141145Liberty PDX CyclerFresenius Medical Care Renal Therapies Group, LLC · 2014 · cites it directly5descendants
- 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
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) | K123630 | Fresenius Liberty Cycler | Fresenius Medical Care North America, Design Cente | 2013 | — |
| +1 | 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 |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K043363 | Fresenius Liberty CyclerSummary page 1…ame:Class Classficaion 11per §876.5630 Legally Marketed Predicate Device (unmodified device): Fresenius Liberty Cycler (K043363) Device Description: The Liberty Cycler is a computer-controlled electro-mechanical medical device designed for use in Automate… | 2005 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K141145 (Fresenius Medical Care Renal Therapies Group, LLC, 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K043363.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Fresenius Liberty Cycler is indicated for acute and chronic peritoneal dilysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123630: 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/K123630
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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