Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zdeer Technology (Henan) Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F2 | Zdeer Technology (Henan) Co., Ltd. | 2026-06-16 | 90 | 0 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 | 124 | 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