Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smec, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
393 daysmedian FDA review time
684 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840367 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORT | Smec, Inc. | 1985-12-11 | 684 | 0 |
| K840037 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC | Smec, Inc. | 1985-02-01 | 393 | 0 |
| K832753 | PERCUTANEOUS BALLOON | Smec, Inc. | 1984-10-13 | 425 | 0 |
| K823739 | INTRA-AORTIC BALLOON SYSTEM | Smec, Inc. | 1983-02-18 | 67 | 0 |
| K823177 | SMEC BALLOON SYSTEM | Smec, Inc. | 1982-12-15 | 50 | 0 |
| K813355 | MODIFICATION OF THE PERCUTAN-BALLOON | Smec, Inc. | 1982-07-02 | 217 | 0 |
| K790755 | SMEC BALLOON CANNULA | Smec, Inc. | 1980-05-14 | 393 | 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