FDA applicant
Wuxi Nest Biotechnology Co., Ltd.
FDA records 4 decisions for Wuxi Nest Biotechnology Co., Ltd. (Wuxi, CN) from 2021 to 2024: 4 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and QBD (Microbial Nucleic Acid Storage And…). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wuxi Nest Biotechnology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Wuxi Nest Biotechnology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Wuxi”
FDA records each applicant name separately; these may or may not be the same firm.