Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Levtrade Intl. (Pty) , Ltd. — 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) |
|---|---|---|---|---|---|
| K943470 | BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS | Levtrade Intl. (Pty) , Ltd. | 1994-09-27 | 70 | 0 |
| K943728 | BURNFREE BURNSOOTHE HYDROGEL | Levtrade Intl. (Pty) , Ltd. | 1994-09-27 | 70 | 0 |
| K921470 | BURNSHIELD FIRE BLANKET | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 | 389 | 0 |
| K921471 | BURNSHIELD TRAUMA DRESSING | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 | 389 | 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