Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sentech Korea Corp. — 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) |
|---|---|---|---|---|---|
| K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 | Sentech Korea Corp. | 2006-10-30 | 115 | 0 |
| K060343 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 | Sentech Korea Corp. | 2006-05-11 | 90 | 0 |
| K053332 | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 | Sentech Korea Corp. | 2006-01-20 | 50 | 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