Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theo Manufacturing BV · 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) |
|---|---|---|---|---|---|
| K150676 | L-Mesitran Dressing Family II- Soft and Tulle | Theo Manufacturing BV | 2015-12-23 | 282 | 0 |
| K053613 | L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESIT | Theo Manufacturing BV | 2007-07-25 | 575 | 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