Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Yian Medical Technology (Haining) 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) |
|---|---|---|---|---|---|
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 | 29 | 0 |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 | 28 | 0 |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-01-09 | 126 | 0 |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-r | Yian Medical Technology (Haining) Co., Ltd. | 2022-05-04 | 55 | 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