Artera, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Artera, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 136 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 |
|---|---|---|
| 2026 | 1 | 136 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Artera, Inc. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SFH | Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis | 1 | 0 |
| SHW | Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis | 1 | 1 |
Review panels
- Pathology (2)
Most recent Artera, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254115 | ArteraAI Breast | SHW | 2026-05-04 | 136 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240068 | De Novo | Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis | 2025-07-31 |
Recalls
openFDA lists no recalls under a recalling firm named Artera, 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 Artera, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Artera, Inc.” (first 2026, latest 2026), 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 Artera, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artera, Inc. is 136 days.
Which FDA product codes appear under Artera, Inc.?
The most frequent FDA product codes under this applicant name are SFH (Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis, 1); SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis, 1).
Next steps
- See all 1 Artera, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SFH, Artera, 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.