Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing Keyi Medical Device Technology 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) |
|---|---|---|---|---|---|
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | 2024-04-19 | 458 | 0 |
| K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | 2020-05-14 | 311 | 0 |
| K190567 | KeYi Spinal Fixation System | Beijing Keyi Medical Device Technology Co., Ltd. | 2019-05-08 | 63 | 0 |
| K162380 | Locking Plate System | Beijing Keyi Medical Device Technology Co., Ltd. | 2017-05-02 | 251 | 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