# K212658: CloudCath Peritoneal Dialysis Drain Set Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cloudcath
- Decided: Feb 9, 2022 after 170 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923065 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043363: Fresenius Liberty Cycler, Fresenius Medical Care North America (2005) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K212658
Methodology: https://510kreport.com/methodology