Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clarity Medical Systems · 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) |
|---|---|---|---|---|---|
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | Clarity Medical Systems | 2011-04-20 | 202 | 2 |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHAL | Clarity Medical Systems | 2009-11-25 | 289 | 2 |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | Clarity Medical Systems | 2009-01-30 | 43 | 0 |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | Clarity Medical Systems | 2008-11-05 | 127 | 3 |
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