Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intermedics Intraocular, Inc. · 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) |
|---|---|---|---|---|---|
| K862070 | INTER-SHARP | Intermedics Intraocular, Inc. | 1986-06-17 | 18 | 0 |
| K841730 | BAILEY LENS SHOOTER | Intermedics Intraocular, Inc. | 1984-11-19 | 208 | 0 |
| K834543 | OCUCARE ULTRASOUND TIP & FREEDOM PACK | Intermedics Intraocular, Inc. | 1984-03-16 | 99 | 0 |
| K832525 | IRRIGATION/ASPIRATION PACK | Intermedics Intraocular, Inc. | 1983-10-04 | 67 | 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