Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Durden Enterprises, 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) |
|---|---|---|---|---|---|
| K912160 | BUTTERFLY DRESSING | Durden Enterprises, Inc. | 1991-10-09 | 146 | 0 |
| K891189 | WEDGE PRESSURE DRESSING | Durden Enterprises, Inc. | 1989-05-24 | 79 | 0 |
| K883557 | NEUROWAVE SYSTEM 2 | Durden Enterprises, Inc. | 1988-12-16 | 119 | 0 |
| K842271 | ELECTRODE, SURFACE EEG ELECTRODE | Durden Enterprises, Inc. | 1984-07-20 | 42 | 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