510(k) · Cleared
ClearedCloudCath Peritoneal Dialysis Drain Set Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cloudcath · FKX System, Peritoneal, Automatic Delivery
Cleared on Feb 9, 2022 as substantially equivalent to K043363 (Fresenius Medical Care North America, 2005) after a 170-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 9, 2022
- Review
- 170 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923065 (1994). 5 ancestors in all, the oldest K902149 (1990). No later device cites it as a predicate yet.
- 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 deviceK212658 CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath · 2022
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) | K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | Cloudcath | 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 11.1 · 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 4…Regulation Number: 21 CFR§ 876.5630 Regulation Description: Peritoneal Dialysis System and Accessories Device Class: II Product Code: FKX 510(k) Number: K043363 510(k) Clearance date: March 31, 2005 Date Prepared: August 18, 2021 Section 5: 510(k) Summary… | 2005 |
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 3 companies; a new generation was cleared every 7.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 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. 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 CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis. The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has…
Read the full statement (112 words)
The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis.
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has associated hardware and software components to allow for data transmission to a healthcare professional.
This system is not intended to provide diagnostic information and is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212658: CloudCath Peritoneal Dialysis Drain Set Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212658
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