Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MKO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221965 | FemDx FalloView | Femdx Medsystems, Inc. | 2023-03-17 | 255 | 0 |
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBIN | Conceptus, Inc. | 1998-01-21 | 90 | 0 |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY | Conceptus, Inc. | 1997-01-31 | 214 | 0 |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | Imagyn Medical, Inc. | 1997-01-31 | 147 | 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