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FDA 510(k)

CloudCath Peritoneal Dialysis Drain Set Monitoring System

K-Number: K212658 · 2022-02-09

ApplicantCloudcath
Decision Date2022-02-09
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CloudCath Peritoneal Dialysis Drain Set Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Cloudcath. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K212658. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CloudCath Peritoneal Dialysis Drain Set Monitoring System?

CloudCath Peritoneal Dialysis Drain Set Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Cloudcath. The 510(k) number is K212658.

When did CloudCath Peritoneal Dialysis Drain Set Monitoring System receive FDA 510(k) clearance?

CloudCath Peritoneal Dialysis Drain Set Monitoring System received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212658.

Who is the listed applicant for CloudCath Peritoneal Dialysis Drain Set Monitoring System?

The FDA 510(k) record lists Cloudcath as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System?

The FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System is FKX.

Related Devices (Code: FKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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