Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgidev Corp. — 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) |
|---|---|---|---|---|---|
| K850729 | ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 | Surgidev Corp. | 1985-04-09 | 46 | 0 |
| K831829 | KARICKHOFF FLYING CORPUSCLE VIEWER | Surgidev Corp. | 1983-10-19 | 134 | 0 |
| K831975 | LEADING EDGE OPHTHALMIC KNIFE | Surgidev Corp. | 1983-08-31 | 72 | 0 |
| K830008 | KARICKHOFF KERATOSCOPE | Surgidev Corp. | 1983-01-26 | 23 | 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