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Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion Device

by Disetronic Medical Systems AG

510(k) K100704

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 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 · Special NumberK100704 Date14 May 2010ClearedStatusActive

Recalls

13 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-1483-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1492-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1481-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1480-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1485-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1491-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1488-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1489-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1490-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1482-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1487-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1486-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
    • Terminated Z-1484-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011

    There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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