Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alltek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
149 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854172 | I.V. WATCH | Alltek, Inc. | 1985-12-05 | 51 | 0 |
| K852030 | PEDIATRIC IV WATCH | Alltek, Inc. | 1985-05-30 | 22 | 0 |
| K852029 | I.V. WATCH | Alltek, Inc. | 1985-05-30 | 22 | 0 |
| K840495 | MANUAL IRRIGATING/ASPIRATING UNIT | Alltek, Inc. | 1984-06-19 | 134 | 0 |
| K834376 | FILTRARE TM ALLVENT TM | Alltek, Inc. | 1984-05-11 | 149 | 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