# Jms North America Corp.

- Location (FDA's records): Hayward, CA
- FDA decisions: 19 (2003–2025): 19 510(k) clearances
- Names in FDA's records: Jms North America Corp. (10); JMS North America Corporation (9)
- Product codes: FIE (10), FOZ (2), MPB (1), FMF (1), DWF (1), FMG (1), FPA (1), FJK (1), ONB (1)
- Predicates its devices cite: 24 (9 its own); citations of its devices by later devices: 12 (9 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
- Jms Co., Ltd.: 5 (https://510kreport.com/company/jms)
- Medisystems Corp.: 2 (https://510kreport.com/company/medisystems)
- Edwards Lifesciences Research Medical: 1 (https://510kreport.com/company/edwards-lifesciences-research-medical)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)
- Becton Dickinson Infusion Therapy Systems, Inc.: 1 (https://510kreport.com/company/becton-dickinson-infusion-therapy-systems)
- Ryan Medical, Inc.: 1 (https://510kreport.com/company/ryan-medical)
- Ofi Biomedica S.P.A.: 1 (https://510kreport.com/company/ofi-biomedica)
- Medflex International, Inc.: 1 (https://510kreport.com/company/medflex-international)

## Firms that cite its devices most
- Dimesol, Inc.: 1 (https://510kreport.com/company/dimesol)
- Summit International Medical Technologies, Inc.: 1 (https://510kreport.com/company/summit-international-medical-technologies)
- Mozarc Medical Us, LLC: 1 (https://510kreport.com/company/mozarc-medical-us)

## Its most-cited devices
- K070234: JMS Sysloc Mini Avf and Apheresis Needle Sets (2007), cited by 2
- K111948: Wingeater V2 (2011), cited by 2
- K142564: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (2014), cited by 1
- K110157: Sysloc Mini V3 (2011), cited by 1
- K030479: JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set (2003), cited by 1
- K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300 (2010), cited by 1

## Recent decisions
- K251877: JMS CAVEO A.V. Fistula Needle Set (Aug 15, 2025)
- K172499: Neoshield (Jun 1, 2018)
- K151017: JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
- K142564: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (Dec 23, 2014)
- K132321: JMS Syringe (Feb 20, 2014)
- K121488: JMS Safe Wing Cath (SWC) (Mar 5, 2013)
- K112178: JMS Apheresis Needle Set Wingeater (R) V2 (Oct 27, 2011)
- K111948: Wingeater V2 (Oct 24, 2011)

Source page: https://510kreport.com/company/jms-north-america