Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Videahealth, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 | 171 | 0 |
| K232384 | Videa Dental Assist | Videahealth, Inc. | 2023-12-15 | 129 | 0 |
| K223296 | Videa Perio Assist | Videahealth, Inc. | 2023-02-06 | 103 | 0 |
| K213795 | Videa Caries Assist | Videahealth, Inc. | 2022-04-21 | 136 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda