Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eurotan Intl. · 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) |
|---|---|---|---|---|---|
| K860489 | EUROTAN BY AYK | Eurotan Intl. | 1986-02-24 | 14 | 0 |
| K853911 | UV-A SUNTANNING EQUIPMENT | Eurotan Intl. | 1985-10-21 | 31 | 0 |
| K840555 | WALDMANN SUNTANNING EQUIP-MODELS'S | Eurotan Intl. | 1984-05-23 | 105 | 0 |
| K820827 | P105 | Eurotan Intl. | 1982-06-25 | 91 | 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