510(k) Report

FDA applicant

Hypoguard USA, Inc.

Edina, MN9 decisions2001–20062 recalls

FDA records 9 decisions for Hypoguard USA, Inc. (Edina, MN) from 2001 to 2006: 9 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Hypoguard USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hypoguard USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hypoguard USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hypoguard USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose5decisions
  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions
  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053079Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc. · 20062cite it
  • K022545Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc. · 20021cites it

What has FDA decided for it lately?

  • K053079Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc. · 2006
  • K051514Assure Pro Blood Glucose Monitoring System, Model 460002Hypoguard USA, Inc. · 2005
  • K041881Advance Micro-Draw Blood Glucose Monitoring System, Model 411100Hypoguard USA, Inc. · 2005
  • K033851Diascreen Reagent Strips for Urinalysis, Models D122OO (2GK), D12100 (1K), D11100 (1G)Hypoguard USA, Inc. · 2004
  • K031388Modification to Hypoguard Advance Blood Glucose Monitoring SystemHypoguard USA, Inc. · 2003
  • K024347Express Blood Glucose Monitoring SystemHypoguard USA, Inc. · 2003
  • K022545Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc. · 2002
  • K020232Hypoguard Advance Blood Glucose Monitoring SystemHypoguard USA, Inc. · 20022 recalls

All 9 as Hypoguard USA, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K020232Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood…Nov 26, 2003
  • K020232Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.Nov 26, 2003