Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caption Health — 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) |
|---|---|---|---|---|---|
| K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2022-01-19 | 313 | 0 |
| K201992 | Caption Guidance | Caption Health | 2020-09-18 | 63 | 0 |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2020-07-22 | 135 | 0 |
| K200755 | Caption Guidance | Caption Health | 2020-04-16 | 24 | 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