# Shinva Ande Healthcare Apparatus Co., Ltd.

- Location (FDA's records): Zibo, CN
- FDA decisions: 6 (2017–2022): 6 510(k) clearances
- Product codes: MEG (2), PNR (1), ONB (1), FOZ (1), FPA (1)
- 510(k) review time since 2016: median 274 days, against 216 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (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
- Jiangyin Caina Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangyin-caina-technology)
- Equashield Medical, Ltd.: 1 (https://510kreport.com/company/equashield-medical)
- Becton Dickinson Infusion Therapy Systems, Inc.: 1 (https://510kreport.com/company/becton-dickinson-infusion-therapy-systems)
- Acta Medical, LLC: 1 (https://510kreport.com/company/acta-medical)

## Firms that cite its devices most
- Epic Medical Pte., Ltd.: 1 (https://510kreport.com/company/epic-medical)
- Cair Lgl: 1 (https://510kreport.com/company/cair-lgl)

## Its most-cited devices
- K193657: Disposable Enteral Feeding Syringe with Enfit Connector (2020), cited by 1
- K201460: Closed System Transfer Device (2022), cited by 1

## Recent decisions
- K201460: Closed System Transfer Device (Nov 23, 2022)
- K220057: Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization (Oct 7, 2022)
- K211484: Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles (Mar 1, 2022)
- K202060: Disposable IV catheter (Jul 23, 2021)
- K193657: Disposable Enteral Feeding Syringe with Enfit Connector (Sep 12, 2020)
- K162601: Infusion Set for Single Use (May 31, 2017)

Source page: https://510kreport.com/company/shinva-ande-healthcare-apparatus