Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Netoptix 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) |
|---|---|---|---|---|---|
| K981958 | LEISEGANG VIDEO COLPOSCOPE | Netoptix Corp. | 1998-10-19 | 137 | 0 |
| K981828 | GALILEO DISPOSABLE HYSTEROSCOPES | Netoptix Corp. | 1998-07-07 | 46 | 0 |
| K974297 | GALILEO DISPOSABLE HYSTEROSCOPES | Netoptix Corp. | 1998-02-13 | 88 | 0 |
| K971896 | GALILEO HIGH RESOLUTION MICRO COUPLER | Netoptix Corp. | 1997-10-10 | 141 | 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