Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgimed Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851157 | SURGIMED - SURGICAL BLADES | Surgimed Corp. | 1985-04-25 | 34 | 0 |
| K840762 | SILVERTORQUE CEREBRAL CATHETER | Surgimed Corp. | 1984-07-13 | 141 | 0 |
| K840763 | SILVERTORQUE CARDIAC CATHETERS | Surgimed Corp. | 1984-06-13 | 111 | 0 |
| K840761 | SILVERTORQUE VISCERAL CATHETER | Surgimed Corp. | 1984-06-11 | 109 | 0 |
| K810689 | BALLOON CATHETER | Surgimed Corp. | 1981-07-28 | 137 | 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