Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Gongdong Medical Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025-12-22 | 84 | 0 |
| K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022-11-17 | 248 | 0 |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020-11-12 | 157 | 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