K212658 is an FDA 510(k) clearance for the CloudCath Peritoneal Dialysis Drain Set Monitoring System. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.
Submitted by Cloudcath (San Francisco, US). The FDA issued a Cleared decision on February 9, 2022 after a review of 170 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
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NCT04515498
Completed
Observational
Industry-sponsored
A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis
| Condition studied |
Peritoneal Dialysis-associated Peritonitis |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Glenn Chertow, MD |
| Sponsor |
CloudCath
(industry)
|
Started 2020-08-19
→
Primary completion 2023-03-31
Primary outcome
Time of peritonitis detection (vs lab measures)
Secondary outcome
Time of peritonitis detection (vs clinical measures)
Study completed - no results published.
This trial concluded in 2023 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov