Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Changzhou Sifary Medical 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) |
|---|---|---|---|---|---|
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 | 266 | 0 |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 | 51 | 0 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 | 217 | 0 |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021-01-29 | 196 | 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