Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fertility Technology Resources, 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) |
|---|---|---|---|---|---|
| K041470 | MORTON IUI CATHETERS | Fertility Technology Resources, Inc. | 2004-11-22 | 173 | 1 |
| K032208 | MONA LISA ASPIRATION NEEDLE | Fertility Technology Resources, Inc. | 2003-12-09 | 144 | 0 |
| K023017 | TUCKER EMBRYO CATHETER | Fertility Technology Resources, Inc. | 2002-12-13 | 94 | 1 |
| K992307 | EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FO | Fertility Technology Resources, Inc. | 1999-09-13 | 66 | 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