Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nexgen Medical Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K102925 | NEXGEN EXPANDABLE CATHETER | Nexgen Medical Systems, Inc. | 2011-11-10 | 402 | 0 |
| K110315 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE | Nexgen Medical Systems, Inc. | 2011-10-20 | 260 | 0 |
| K102979 | NEXGEN PERIPHERAL GUIDE CATHETER | Nexgen Medical Systems, Inc. | 2011-01-18 | 104 | 0 |
| K090932 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL | Nexgen Medical Systems, Inc. | 2009-09-24 | 175 | 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