Cognoa, Inc.: FDA clearances and approvals
Cognoa, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 144 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 144 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cognoa, Inc.'s cleared 510(k)s took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QPF | Pediatric Autism Spectrum Disorder Diagnosis Aid | 2 | 1 |
Review panels
- Neurology (2)
Most recent Cognoa, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243558 | Canvas Dx | QPF | 2025-04-11 | 144 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200069 | De Novo | Pediatric Autism Spectrum Disorder Diagnosis Aid | 2021-06-02 |
Recalls
openFDA lists no recalls under a recalling firm named Cognoa, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Cognoa, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05223374: Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting (Completed, started 2022-03-01)
- NCT04151290: Cognoa ASD Diagnosis Aid Validation Study (Completed, started 2019-08-07)
Frequently asked questions
How many FDA 510(k) clearances does Cognoa, Inc. have?
Cognoa, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Cognoa, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cognoa, Inc.'s cleared 510(k)s is 144 days.
What devices does Cognoa, Inc. make?
Its most frequent FDA product codes are QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid, 2).
Has Cognoa, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cognoa, Inc. Related entities may recall under other names.
Next steps
- See all 1 Cognoa, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QPF, Cognoa, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.