Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optovue, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
219 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222166 | SOLIX | Optovue, Inc. | 2022-11-09 | 111 | 0 |
| K180660 | Avanti | Optovue, Inc. | 2018-06-08 | 86 | 0 |
| K163475 | iVue | Optovue, Inc. | 2017-06-09 | 179 | 0 |
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016-02-11 | 111 | 0 |
| K133892 | IVUE 500 | Optovue, Inc. | 2014-03-19 | 89 | 0 |
| K130656 | IFUSION | Optovue, Inc. | 2013-07-03 | 113 | 0 |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | 2013-01-18 | 219 | 1 |
| K122572 | ICAM FUNDUS CAMERA | Optovue, Inc. | 2013-01-11 | 141 | 0 |
| K120238 | RTVUE XR OCT | Optovue, Inc. | 2012-04-03 | 68 | 0 |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | Optovue, Inc. | 2011-09-08 | 100 | 1 |
| K103266 | ISTAND | Optovue, Inc. | 2011-06-03 | 211 | 0 |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | 2010-09-15 | 106 | 1 |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | 2010-06-17 | 83 | 0 |
| K091404 | IVUE, MODEL 100 | Optovue, Inc. | 2010-04-22 | 345 | 2 |
| K071250 | CA, MODEL: CAM | Optovue, Inc. | 2007-09-28 | 147 | 0 |
| K062552 | RTVUE | Optovue, Inc. | 2006-10-06 | 37 | 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