Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sota Precision Optics, Inc. — 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) |
|---|---|---|---|---|---|
| K110886 | CLIO/CLIOSOFT | Sota Precision Optics, Inc. | 2011-06-30 | 92 | 0 |
| K061175 | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES | Sota Precision Optics, Inc. | 2006-05-23 | 26 | 0 |
| K032341 | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 | Sota Precision Optics, Inc. | 2003-08-25 | 27 | 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