Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ophthalmic Technologies, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
94 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042885 | OCT-OPTHALMOSCOPE | Ophthalmic Technologies, Inc. | 2005-01-21 | 94 | 0 |
| K031391 | HF MODULE WITH TRANSDUCERS | Ophthalmic Technologies, Inc. | 2003-06-20 | 49 | 0 |
| K030770 | OTI SCAN WITH TRANSDUCERS | Ophthalmic Technologies, Inc. | 2003-03-27 | 16 | 0 |
| K024114 | A-SCAN 100 | Ophthalmic Technologies, Inc. | 2003-01-10 | 28 | 0 |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | 1999-04-04 | 86 | 0 |
| K974522 | 3D I-SCAN | Ophthalmic Technologies, Inc. | 1998-02-25 | 85 | 0 |
| K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE | Ophthalmic Technologies, Inc. | 1997-06-25 | 49 | 0 |
| K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996-05-13 | 90 | 0 |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | 1995-10-18 | 36 | 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