Data / Medical devices / United States / Cognoa, Inc.
Cognoa, Inc.: FDA-registered device maker in Newport Beach, CA, United States, 2 510(k) clearances
Cognoa, Inc. is registered with the FDA (registration 3020832299) in Newport Beach, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020832299
- Address
- 5000 Campus Dr, Newport Beach, CA, United States, 92660
- Owner or operator
- Cognoa, Inc. (10083227)
- Roles
- Manufacturer
- First device listed
- November 3, 2021
- Registered through
- 2027
- Brand names listed
- Canvas Dx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pediatric Autism Spectrum Disorder Diagnosis Aid | QPF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 11, 2025 | K243558 | Canvas Dx | QPF | Substantially Equivalent | Cognoa, Inc. | accessdata.fda.gov |
| June 2, 2021 | DEN200069 | Cognoa ASD Diagnosis Aid | QPF | Unknown | Cognoa, Inc. | accessdata.fda.gov |
Updated April 11, 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.