# Hypoguard USA, Inc.

- Location (FDA's records): Edina, MN
- FDA decisions: 9 (2001–2006): 9 510(k) clearances
- Product codes: CGA (5), NBW (2), JIL (2)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- Arkray Factory USA, Inc.: 3 (https://510kreport.com/company/arkray-factory-usa)

## Its most-cited devices
- K053079: Assure Pro Blood Glucose Monitoring System, Model 460001 (2006), cited by 2
- K022545: Glucobalance Data Management Software, Model 555020 (2002), cited by 1

## Recent decisions
- K053079: Assure Pro Blood Glucose Monitoring System, Model 460001 (Mar 28, 2006)
- K051514: Assure Pro Blood Glucose Monitoring System, Model 460002 (Oct 4, 2005)
- K041881: Advance Micro-Draw Blood Glucose Monitoring System, Model 411100 (Mar 25, 2005)
- K033851: Diascreen Reagent Strips for Urinalysis, Models D122OO (2GK), D12100 (1K), D11100 (1G) (Mar 2, 2004)
- K031388: Modification to Hypoguard Advance Blood Glucose Monitoring System (May 22, 2003)
- K024347: Express Blood Glucose Monitoring System (Mar 28, 2003)
- K022545: Glucobalance Data Management Software, Model 555020 (Oct 11, 2002)
- K020232: Hypoguard Advance Blood Glucose Monitoring System (Feb 12, 2002)

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