Paige.Ai, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Paige.Ai, Inc.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 169 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 90 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 248 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paige.Ai, Inc. took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QKQ | Digital Pathology Image Viewing And Management Software | 2 | 2 |
| QPN | Software Algorithm Device To Assist Users In Digital Pathology | 1 | 0 |
Review panels
- Pathology (3)
Most recent Paige.Ai, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241273 | FullFocus | QKQ | 2025-01-09 | 248 |
| K201005 | FullFocus | QKQ | 2020-07-15 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200080 | De Novo | Software Algorithm Device To Assist Users In Digital Pathology | 2021-09-21 |
Recalls
openFDA lists no recalls under a recalling firm named Paige.Ai, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Paige.Ai, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Paige.Ai, Inc.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Paige.Ai, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paige.Ai, Inc. is 169 days.
Which FDA product codes appear under Paige.Ai, Inc.?
The most frequent FDA product codes under this applicant name are QKQ (Digital Pathology Image Viewing And Management Software, 2); QPN (Software Algorithm Device To Assist Users In Digital Pathology, 1).
Next steps
- See all 2 Paige.Ai, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QKQ, Paige.Ai, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.