Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smartdata Suzhou 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) |
|---|---|---|---|---|---|
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd. | 2019-09-06 | 107 | 0 |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | Smartdata Suzhou Co., Ltd. | 2019-06-07 | 30 | 0 |
| K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. | 2019-04-17 | 169 | 0 |
| K181509 | Endorate Valve Sets | Smartdata Suzhou Co., Ltd. | 2018-07-06 | 28 | 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