Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hamilton Thorne Biosciences — 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) |
|---|---|---|---|---|---|
| K063636 | ZILOS-TK | Hamilton Thorne Biosciences | 2007-04-24 | 138 | 0 |
| K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | Hamilton Thorne Biosciences | 2005-04-28 | 34 | 0 |
| DEN040009 | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK | Hamilton Thorne Biosciences | 2004-11-04 | 71 | 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