Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Algotec Systems, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
151 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033013 | MDIFICATION TO MEDIPRIME | Algotec Systems, Ltd. | 2003-11-25 | 60 | 0 |
| K023936 | MODIFICATION TO MEDIPRIME | Algotec Systems, Ltd. | 2002-12-20 | 24 | 0 |
| K002894 | MEDIPRIME | Algotec Systems, Ltd. | 2000-12-05 | 78 | 0 |
| K980648 | PRO VISION | Algotec Systems, Ltd. | 1998-07-20 | 151 | 0 |
| K954678 | PRO VISION | Algotec Systems, Ltd. | 1996-01-05 | 87 | 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