Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ophthalmed, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015-06-25 | 268 | 0 |
| K050807 | 20G SMA LASER FIBER, MODEL LF100 | Ophthalmed, LLC | 2005-09-21 | 175 | 0 |
| K021696 | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL | Ophthalmed, LLC | 2002-08-20 | 90 | 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