Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hamilton Thorne, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting Sys | Hamilton Thorne, Inc. | 2021-07-02 | 326 | 0 |
| K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | 2019-09-18 | 98 | 0 |
| K190383 | GM501 Wash | Hamilton Thorne, Inc. | 2019-09-05 | 198 | 0 |
| K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMIL | Hamilton Thorne, Inc. | 2012-04-24 | 106 | 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