Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nfocus Neuromedical, Inc. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091952 | ACTA VESSEL OCCLUSION SYSTEM (VOS) | Nfocus Neuromedical, Inc. | 2010-09-10 | 436 | 0 |
| K090918 | NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER | Nfocus Neuromedical, Inc. | 2009-07-30 | 120 | 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