Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuxi Nest Biotechnology 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) |
|---|---|---|---|---|---|
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 | 129 | 0 |
| K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 | 89 | 0 |
| K211256 | Disposable Sampler Viral Transport Media | Wuxi Nest Biotechnology Co., Ltd. | 2022-05-20 | 389 | 0 |
| K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM | Wuxi Nest Biotechnology Co., Ltd. | 2021-09-20 | 220 | 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