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Maersk Medical Pureline Comfort Subcutaneous Infusion Set

by P/L Biomedical

510(k) K972135

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 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 NumberK972135 Date26 Aug 1997ClearedStatusActive

Recalls

16 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-0885-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0883-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0888-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0884-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0892-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0886-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0889-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0893-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0891-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0890-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0887-2015 FDA Class II initiated 20 Nov 2014
    • Terminated Z-0894-2015 FDA Class II initiated 20 Nov 2014

    Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify

  • 4 recalls, same reason

    • Terminated Z-0359-2017 FDA Class II initiated 7 Nov 2014
    • 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

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  • Withdrawn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

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