Data / Medical devices / United States / Cytovale, Inc.
Cytovale, Inc.: FDA-registered device maker in South San Francisco, CA, United States, 3 510(k) clearances
Cytovale, Inc. is registered with the FDA (registration 3017448032) in South San Francisco, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017448032
- Address
- 2 Tower Pl Fl 18, South San Francisco, CA, United States, 94080
- Owner or operator
- Cytovale, Inc. (10088591)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 23, 2023
- Registered through
- 2026
- Brand names listed
- Cytovale Cleanse, Cytovale Diluent, Cytovale Reagent Kit, Cytovale System, IntelliSep Cartridge, IntelliSep Quality Control Kit, IntelliSep test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Deformability Cytometry For Sepsis Risk Assessment | QUT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| November 19, 2025 | K250912 | IntelliSep Test | QUT | Substantially Equivalent | Cytovale, Inc. | accessdata.fda.gov |
| March 21, 2025 | K250513 | IntelliSep Test (CV-ICG-048) | QUT | Substantially Equivalent | Cytovale, Inc. | accessdata.fda.gov |
| December 20, 2022 | K220991 | IntelliSep test | QUT | Substantially Equivalent | Cytovale, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixture, Hematology Quality Control
- All makers of Deformability Cytometry For Sepsis Risk Assessment
Updated November 19, 2025. 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.