Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medisurg , Ltd. · 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) |
|---|---|---|---|---|---|
| K063468 | THE FUGO BLADE FOR DENTISTRY | Medisurg , Ltd. | 2007-04-18 | 153 | 0 |
| K050933 | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 | Medisurg , Ltd. | 2005-12-09 | 239 | 0 |
| K041019 | THE FUGO BLADE FOR GLAUCOMA | Medisurg , Ltd. | 2004-10-08 | 171 | 0 |
| K001498 | THE FUGO BLADE | Medisurg , Ltd. | 2000-08-10 | 87 | 1 |
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