Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Origen Biomedical, 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) |
|---|---|---|---|---|---|
| K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER | Origen Biomedical, Inc. | 2012-07-26 | 209 | 9 |
| K021702 | CRYOBAG, MODEL CB | Origen Biomedical, Inc. | 2002-08-06 | 75 | 0 |
| K003288 | ORIGEN DUAL LUMEN CATHETER | Origen Biomedical, Inc. | 2001-06-08 | 231 | 0 |
| K003145 | ORIGEN BLADDER HOLDER | Origen Biomedical, Inc. | 2001-04-20 | 192 | 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