# Berpu Medical Technology Co., Ltd.

- Location (FDA's records): Wenzhou, CN
- FDA decisions: 9 (2016–2024): 9 510(k) clearances
- Product codes: FMF (4), FMI (3), MEG (2)
- 510(k) review time since 2016: median 217 days, against 200 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 16 (3 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
- Shandong Weigao Group Medical Polymer Co., Ltd.: 2 (https://510kreport.com/company/shandong-weigao-group-medical-polymer)
- Zhejiang Kangkang Medical-Devices Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kangkang-medical-devices)
- Ypsomed AG: 1 (https://510kreport.com/company/ypsomed)
- Jiangsu Caina Medical Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-caina-medical)
- Jiangsu Micsafe Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-micsafe-medical-technology)
- Terumo (Philippines) Corporation: 1 (https://510kreport.com/company/terumo-philippines)

## Firms that cite its devices most
- Sichuan Prius Biotechnology Co., Ltd.: 3 (https://510kreport.com/company/sichuan-prius-biotechnology)
- Wepon Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/wepon-medical-technology)
- Jiangsu Caina Medical Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-caina-medical)
- Azur Medical Company, Inc.: 1 (https://510kreport.com/company/azur-medical)
- Chirana T. Injecta: 1 (https://510kreport.com/company/chirana-t-injecta)
- Dlp Medical Products, Corp.: 1 (https://510kreport.com/company/dlp-medical-products)
- Zhejiang Kindly Medical Device Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kindly-medical-device)
- Zhejiang Kangkang Medical-Devices Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kangkang-medical-devices)

## Its most-cited devices
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), cited by 8
- K162180: Disposable Insulin Syringe (2016), cited by 3
- K181447: Safety insulin needle for single use (2019), cited by 3
- K213811: Sterile Hypodermic Syringes for Single Use (2022), cited by 1
- K220061: Safety Insulin Syringes (2022), cited by 1

## Recent decisions
- K232165: Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles (Feb 1, 2024)
- K221045: Insulin Syringes without needle (Nov 3, 2022)
- K220061: Safety Insulin Syringes (Aug 23, 2022)
- K213158: Syringe with permanently attached needle (Jul 21, 2022)
- K213811: Sterile Hypodermic Syringes for Single Use (May 12, 2022)
- K212514: Safety Pen Needle for Single Use, Insulin Pen Needles (Apr 29, 2022)
- K181447: Safety insulin needle for single use (Mar 12, 2019)
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (Aug 9, 2018)

Source page: https://510kreport.com/company/berpu-medical-technology