# Jiangsu Caina Medical Co.,Ltd

- Location (FDA's records): Jiangyin, CN
- FDA decisions: 21 (2018–2024): 21 510(k) clearances
- Product codes: FMI (3), MEG (3), JKA (3), PNR (3), FMF (2), QEH (1), FPA (1), PTI (1), NGT (1), CAZ (1), LHI (1), PIO (1)
- 510(k) review time since 2016: median 165 days, against 189 for FDA's reviews in the same codes and years (9 of 15 faster)
- Predicates its devices cite: 25 (0 its own); citations of its devices by later devices: 18 (0 its own)
- Recalls linked to its devices: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Yangzhou Medline Industry, Co., Ltd.: 2 (https://510kreport.com/company/yangzhou-medline-industry)
- Sol-Millennium Medical, Inc.: 2 (https://510kreport.com/company/sol-millennium-medical)
- Neomed, Inc.: 2 (https://510kreport.com/company/neomed)
- Vesco Medical, LLC: 1 (https://510kreport.com/company/vesco-medical)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Shandong Weigao Group Medical Polymer Co., Ltd.: 1 (https://510kreport.com/company/shandong-weigao-group-medical-polymer)
- Berpu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/berpu-medical-technology)

## Firms that cite its devices most
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.: 2 (https://510kreport.com/company/anhui-hongyu-wuzhou-medical-manufacturer)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Sichuan Prius Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/sichuan-prius-biotechnology)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Greiner Bio-One North America, Inc.: 1 (https://510kreport.com/company/greiner-bio-one-north-america)
- Ningbo Medsun Medical Co., Ltd.: 1 (https://510kreport.com/company/ningbo-medsun-medical)
- Feeltech Co., Ltd.: 1 (https://510kreport.com/company/feeltech)
- Berpu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/berpu-medical-technology)

## Its most-cited devices
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), cited by 6
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), cited by 5
- K193526: Syringe with safety needle, Safety needle (2020), cited by 4
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), cited by 2
- K192677: Safety Insulin Pen Needle (2020), cited by 1

## Recent decisions
- K232781: Safety Sliding Blood Collection Set (Mar 7, 2024)
- K233190: ENFit Adaptor (Jan 18, 2024)
- K230635: Pen Needle (Jun 2, 2023)
- K222834: Safety Push Button Blood Collection Set (Jan 5, 2023)
- K221406: Vented Vial Transfer Pin (Oct 28, 2022)
- K222155: O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) (Sep 16, 2022)
- K220184: Pump Alignment Syringe (Jul 21, 2022)
- K220060: Pre-filled Syringe with Saline (Jun 10, 2022)

Source page: https://510kreport.com/company/jiangsu-caina-medical