# Arkray Factory USA, Inc.

- Location (FDA's records): Edina, MN
- FDA decisions: 9 (2007–2011): 9 510(k) clearances
- Product codes: NBW (5), CGA (4)
- Predicates its devices cite: 6 (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
- Hypoguard USA, Inc.: 3 (https://510kreport.com/company/hypoguard-usa)
- Arkray USA, Inc.: 2 (https://510kreport.com/company/arkray-usa)
- Mycare Team, Inc.: 1 (https://510kreport.com/company/mycare-team)

## Firms that cite its devices most
- Arkray Factory, Inc.: 2 (https://510kreport.com/company/arkray-factory)

## Its most-cited devices
- K082417: Glucocard 01-Mini Blood Glucose Monitoring System, Model 73110 (2008), cited by 1
- K073416: Arkray Glucocard 01 Blood Monitoring System (2008), cited by 1

## Recent decisions
- K110709: Ark Care Diabetes Managment System (May 19, 2011)
- K093819: Arkray Diabetes Data Management Software (SMBG Viewer) (Jun 9, 2010)
- K092104: Assure Platinum Blood Glucose Monitoring System (Nov 24, 2009)
- K091102: Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems (Oct 23, 2009)
- K090653: Pocketchem EZ Blood Glucose Monitoring System (Oct 9, 2009)
- K090332: Assure Pro Blood Glucose Monitoring System, Model 46001 (Aug 14, 2009)
- K082417: Glucocard 01-Mini Blood Glucose Monitoring System, Model 73110 (Oct 21, 2008)
- K073416: Arkray Glucocard 01 Blood Monitoring System (Jun 13, 2008)

Source page: https://510kreport.com/company/arkray-factory-usa