Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Ophthalmic Industries Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
169 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | Intl. Ophthalmic Industries Corp. | 1996-07-23 | 85 | 0 |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | 1989-10-31 | 104 | 0 |
| K894511 | MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT | Intl. Ophthalmic Industries Corp. | 1989-10-17 | 90 | 0 |
| K894512 | PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS | Intl. Ophthalmic Industries Corp. | 1989-10-17 | 90 | 0 |
| K823088 | ASPITRON | Intl. Ophthalmic Industries Corp. | 1983-04-06 | 169 | 0 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 | 61 | 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