Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Embol-X, 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) |
|---|---|---|---|---|---|
| K022071 | EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA L | Embol-X, Inc. | 2003-02-14 | 233 | 1 |
| K020693 | AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CA | Embol-X, Inc. | 2002-09-05 | 185 | 1 |
| K002973 | EMBOL-X INTRODUCER, MODEL CF00200 | Embol-X, Inc. | 2001-04-26 | 216 | 0 |
| K980631 | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA | Embol-X, Inc. | 1999-02-02 | 349 | 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