Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wmi Enterprises, LLC — 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) |
|---|---|---|---|---|---|
| K101035 | WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL | Wmi Enterprises, LLC | 2010-10-29 | 198 | 0 |
| K100969 | WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-20 | Wmi Enterprises, LLC | 2010-09-20 | 165 | 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