# Arkray Factory, Inc.

- Location (FDA's records): Koka-Shi, JP
- FDA decisions: 6 (2014–2019): 6 510(k) clearances
- Product codes: NBW (3), CGA (2), PDJ (1)
- 510(k) review time since 2016: median 219 days, against 173 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 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
- Tosoh Bioscience, Inc.: 2 (https://510kreport.com/company/tosoh-bioscience)
- Arkray Factory USA, Inc.: 2 (https://510kreport.com/company/arkray-factory-usa)

## Its most-cited devices
- K124021: Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System (2014), cited by 1

## Recent decisions
- K183306: GLUCOCARD® W onyx Blood Glucose Monitoring System (Apr 10, 2019)
- K170064: GLUCOCARD W Blood Glucose Monitoring System (Aug 16, 2017)
- K162822: ADAMS A1c HA-8180V, CALIBRATOR 80 (Jun 29, 2017)
- K142336: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (Sep 17, 2014)
- K142035: Glucocard 01-Mini Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System (Sep 5, 2014)
- K124021: Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System (Jun 30, 2014)

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