Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dilon Technologies, Inc. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110384 | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | 2011-05-03 | 82 | 0 |
| K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 | Dilon Technologies, Inc. | 1999-03-16 | 90 | 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