Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ya-Man, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
520 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 2025-10-29 | 243 | 0 |
| K244048 | Medi Lift Mask | Ya-Man, Ltd. | 2025-01-16 | 16 | 0 |
| K220198 | Medi Lift PLUS | Ya-Man, Ltd. | 2023-06-28 | 520 | 0 |
| K112016 | L-SER KO LAMP | Ya-Man, Ltd. | 2012-02-10 | 211 | 0 |
| K032944 | YA-MAN LASER 21 | Ya-Man, Ltd. | 2003-12-19 | 88 | 0 |
| K011021 | LASER 20 | Ya-Man, Ltd. | 2001-10-09 | 188 | 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