Disetronic Panomat Pump

• 2 recalls, same reason

  • Terminated Z-1227-04 FDA Unclassified (pre-2012) ·initiated 17 May 2004 ·on shared 510(k) K915566
  • Terminated Z-1228-04 FDA Unclassified (pre-2012) ·initiated 17 May 2004 ·on shared 510(k) K915566

  Lack of assurance of sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K915566 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disetronic Rapid Subcutaneous Infusion Set and Disteronic Rapid D Subcutaneous Infusion Set

  Class II

  FDA 510(k) K003977 Active Cleared 15 Feb 2001

• Modification to D-Tronplus

  Class II

  FDA 510(k) K043000 Active Cleared 1 Dec 2004

• Modification to Disetronic D-Tronplus Insulin Infusion Pump

  Class II

  FDA 510(k) K022831 Active Cleared 11 Sep 2002

• Disetronic D-Modem

  Class II

  FDA 510(k) K943952 Active Cleared 7 Oct 1995

• Disetronic Pen

  Class II

  FDA 510(k) K982966 Active Cleared 19 Oct 1998

• Ultraflex Infusion Set

  Class II

  FDA 510(k) K033892 Active Cleared 9 Mar 2004

See all devices from Disetronic Medical Systems →