Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Van Dellen, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
145 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873465 | VAN DELLEN BACTERIA FILTER | Van Dellen, Ltd. | 1988-01-20 | 145 | 0 |
| K873463 | VAN DELLEN ASPIRATING TUBING | Van Dellen, Ltd. | 1987-11-23 | 87 | 0 |
| K873464 | VAN DELLEN CANNULA | Van Dellen, Ltd. | 1987-11-23 | 87 | 0 |
| K873462 | VAN DELLEN ASPIRATOR | Van Dellen, Ltd. | 1987-09-25 | 28 | 0 |
| K873162 | VAN DELLEN RETROBULBAR NEEDLE | Van Dellen, Ltd. | 1987-09-04 | 24 | 0 |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Van Dellen, Ltd. | 1987-09-04 | 24 | 0 |
| K873164 | VAN DELLEN HEALON CANNULA | Van Dellen, Ltd. | 1987-09-04 | 24 | 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