Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Saeyang Microtech Co., 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) |
|---|---|---|---|---|---|
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | 2022-09-19 | 279 | 0 |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015-04-24 | 324 | 0 |
| K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | 268 | 0 |
| K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | 269 | 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