Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ep Dynamics, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111603 | LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM | Ep Dynamics, Inc. | 2012-08-23 | 442 | 0 |
| K090867 | AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK | Ep Dynamics, Inc. | 2009-07-30 | 121 | 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