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Hypoguard Advance Blood Glucose Monitoring System

by Hypoguard USA, Inc.

510(k) K020232

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020232 Date12 Feb 2002ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0275-04 FDA Unclassified (pre-2012) initiated 26 Nov 2003
    • Terminated Z-0276-04 FDA Unclassified (pre-2012) initiated 26 Nov 2003

    When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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