CloudCath Peritoneal Dialysis Drain Set Monitoring System— 510(k) K212658
Substantially EquivalentCloudcath
FDA 510(k) clearance K212658 for CloudCath Peritoneal Dialysis Drain Set Monitoring System, Substantially Equivalent on 2022-02-09. Applicant: Cloudcath. Device class: 2.
Clearance details
- Applicant
- Cloudcath
- Product code
- Code FKX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code FKX
view all- K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) +4 more
- K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- K222318 — Fresenius Liberty Select Cycler
- K212522 — Lilliput APD System
Adverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.