Data / Medical devices / United States / Gastroklenz Inc. Dba Cloudcath
Gastroklenz Inc. Dba Cloudcath: FDA-registered device maker in San Francisco, CA, United States, 1 510(k) clearance
Gastroklenz Inc. Dba Cloudcath is registered with the FDA (registration 3015882716) in San Francisco, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015882716
- Address
- 665 3rd Street, Suite 250, San Francisco, CA, United States, 94107
- Owner or operator
- GastroKlenz Inc. dba CloudCath (10085457)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 20, 2022
- Registered through
- 2026
- Brand names listed
- CloudCath, CloudCath Connect - Patient Monitoring Software, CloudCath Drain Set - Baxter Configuration, CloudCath Drain Set - Fresenius Configuration, CloudCath Sensor (Sensing Hardware)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Peritoneal, Automatic Delivery | FKX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 2022 | K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | FKX | Substantially Equivalent | Cloudcath | accessdata.fda.gov |
Compare with other makers
Updated February 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.