Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mogul Enterprises · 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) |
|---|---|---|---|---|---|
| K030852 | 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS M | Mogul Enterprises | 2003-07-10 | 114 | 0 |
| K011734 | 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | Mogul Enterprises | 2001-07-03 | 28 | 0 |
| K993698 | SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX | Mogul Enterprises | 2000-08-16 | 288 | 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