Data / Medical devices / United States / Diality, Inc.
Diality, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Diality, Inc. is registered with the FDA (registration 3015349756) in Irvine, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015349756
- Address
- 181 Technology Dr Ste 150, Irvine, CA, United States, 92618
- Owner or operator
- Diality Inc (10091317)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 21, 2024
- Registered through
- 2026
- Brand names listed
- Moda-flx Hemodialysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 2, 2024 | K233798 | Moda-flx Hemodialysis System and Cartridge | KDI | Substantially Equivalent | Diality, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Subsystem, Water Purification
Updated August 2, 2024. 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.