Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fluoptics — 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) |
|---|---|---|---|---|---|
| K190891 | Fluobeam LX | Fluoptics | 2019-07-31 | 117 | 0 |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Co | Fluoptics | 2018-11-02 | 315 | 0 |
| K132475 | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CO | Fluoptics | 2014-05-07 | 273 | 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