Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endocross, Ltd. — 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) |
|---|---|---|---|---|---|
| K092174 | ENABLER-P CATHETER SYSTEM, MODEL 3000 | Endocross, Ltd. | 2009-12-30 | 162 | 0 |
| K083833 | ENABLER-P CATHETER, 1000 PART NUMBER:1160 | Endocross, Ltd. | 2009-05-22 | 150 | 0 |
| K082339 | ENABLER-P SUPPORT CATHETER | Endocross, Ltd. | 2008-11-20 | 98 | 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