Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Claripi, 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) |
|---|---|---|---|---|---|
| K203783 | ClariPulmo | Claripi, Inc. | 2022-04-06 | 464 | 0 |
| K203785 | ClariSIGMAM | Claripi, Inc. | 2021-09-10 | 256 | 0 |
| K212074 | ClariCT.AI | Claripi, Inc. | 2021-07-27 | 25 | 0 |
| K183460 | ClariCT.AI | Claripi, Inc. | 2019-06-13 | 182 | 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