Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Asahi Optical Co. C/O Rosati Associates, P.C. · 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) |
|---|---|---|---|---|---|
| K885133 | APACERAM ARTIFICIAL DENTAL IMPLANT | Asahi Optical Co. C/O Rosati Associates, P.C. | 1989-09-05 | 267 | 0 |
| K893134 | APACERAM OSSICULAR PROSTHESIS | Asahi Optical Co. C/O Rosati Associates, P.C. | 1989-08-03 | 100 | 0 |
| K872089 | APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) | Asahi Optical Co. C/O Rosati Associates, P.C. | 1987-08-14 | 74 | 0 |
| K861960 | ZIMLITE LENS | Asahi Optical Co. C/O Rosati Associates, P.C. | 1986-06-09 | 20 | 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