510(k) · Cleared
ClearedLilliput APD System
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 Apr 15, 2022 as substantially equivalent to K141145 (Fresenius Medical Care Renal Therapies Group, LLC, 2014) and 1 other predicate after a 247-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Apr 15, 2022
- Review
- 247 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 2
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 deviceK212522 Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
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) | 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 |
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 11.2 · 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? (2)
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 |
|---|---|---|---|
| * | K141145 | Liberty PDX CyclerSummary page 4…Panel: Gastroenterology/Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate devices are the Liberty PDx Cycler cleared under K141145 and the Fresenius Liberty Select Cycler cleared under K181108. 5.4. Device Description 5.4.1. Device Identificatio… | 2014 |
| * | K181108 | Fresenius Liberty Select CyclerSummary page 4…y Marketed Predicate Device The legally marketed predicate devices are the Liberty PDx Cycler cleared under K141145 and the Fresenius Liberty Select Cycler cleared under K181108. 5.4. Device Description 5.4.1. Device Identification The Lilliput APD System is available in one (1) configuratio… | 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 28 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 6 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K141145.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings
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/K212522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212522: Lilliput APD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212522
Report an extraction error
Are you the manufacturer?
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