# Wuxi Nest Biotechnology Co., Ltd.

- Location (FDA's records): Wuxi, CN
- FDA decisions: 4 (2021–2024): 4 510(k) clearances
- Product codes: FMF (2), QBD (1), JSM (1)
- 510(k) review time since 2016: median 129 days, against 130 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novo Nordisk, Inc.: 2 (https://510kreport.com/company/novo-nordisk)
- Longhorn Vaccines and Diagnostics, LLC: 1 (https://510kreport.com/company/longhorn-vaccines-and-diagnostics)
- Copan Diagnostics, Inc.: 1 (https://510kreport.com/company/copan-diagnostics)

## Firms that cite its devices most
- Jiangsu Enjosim Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-enjosim-medical-technology)

## Its most-cited devices
- K240961: Disposable Pen Injector Assembly (2024), cited by 1

## Recent decisions
- K240961: Disposable Pen Injector Assembly (Aug 15, 2024)
- K240774: Pen Injector (Jun 18, 2024)
- K211256: Disposable Sampler Viral Transport Media (May 20, 2022)
- K210440: Disposable Sampler Inactivated Transport Media, Nest ITM (Sep 20, 2021)

Source page: https://510kreport.com/company/wuxi-nest-biotechnology