Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wuxi Xinzhongrui Baby Supplies 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) |
|---|---|---|---|---|---|
| K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2021-08-26 | 337 | 0 |
| K151284 | Electric Double Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-12-21 | 221 | 0 |
| K142479 | MEGNA BREAST PUMPS | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-02-24 | 173 | 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