Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chiron Intraoptics · 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) |
|---|---|---|---|---|---|
| K925631 | PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE | Chiron Intraoptics | 1993-07-29 | 262 | 0 |
| K924165 | OPTISOL-GS CORNEAL STORAGE MEDIA | Chiron Intraoptics | 1992-10-06 | 48 | 0 |
| K921729 | OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED | Chiron Intraoptics | 1992-06-09 | 76 | 0 |
| K921728 | DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED | Chiron Intraoptics | 1992-06-09 | 76 | 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