Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opti Medical Systems, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021-08-02 | 474 | 0 |
| K131126 | OPTI CCA-TS2 | Opti Medical Systems, Inc. | 2013-08-22 | 122 | 0 |
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | Opti Medical Systems, Inc. | 2011-01-07 | 444 | 1 |
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