Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neomedix 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) |
|---|---|---|---|---|---|
| K061258 | TRABECTOME HIGH FREQUENCY GENERATOR/LP | Neomedix Corp. | 2006-05-18 | 13 | 0 |
| K040584 | NMX-1000 | Neomedix Corp. | 2004-04-22 | 48 | 0 |
| K040239 | SUPRAFLOW CONSOLE | Neomedix Corp. | 2004-02-17 | 15 | 1 |
| K024304 | MICROSURGICAL BIPOLAR HANDPIECE | Neomedix Corp. | 2003-02-25 | 63 | 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