Skip to content

Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps

by Unomedical A/S Infusion Devices

510(k) K120872

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 NumberK120872 Date20 Apr 2012ClearedStatusActive

Recalls

10 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0355-2017 FDA Class II initiated 7 Nov 2014
    • Terminated Z-0357-2017 FDA Class II initiated 7 Nov 2014
    • Terminated Z-0358-2017 FDA Class II initiated 7 Nov 2014

    Tubing detachment

  • 7 recalls, same reason

    • Terminated Z-0600-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0597-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0595-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0601-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0596-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0594-2014 FDA Class II initiated 19 Nov 2013
    • Terminated Z-0599-2014 FDA Class II initiated 19 Nov 2013

    Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent