Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inntec, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052059 | IUI CATHETER, MODEL 9057 | Inntec, Inc. | 2005-11-22 | 116 | 0 |
| K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | Inntec, Inc. | 2005-10-07 | 101 | 0 |
| K050521 | EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, | Inntec, Inc. | 2005-05-02 | 62 | 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