Disetronic H-Tronplus Insulin Infusion Pump

• • Terminated Z-1197-03 FDA Unclassified (pre-2012) ·initiated 21 Jul 2003

  Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

510(k) Number

K023471 ↗

FDA Product Code

LZG

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 →

• What is the Disetronic H-Tronplus Insulin Infusion Pump used for?

  The Disetronic H-Tronplus Insulin Infusion Pump is designed for the controlled delivery of insulin as prescribed by a physician for patients with insulin-dependent diabetes mellitus who do not have optimum blood glucose control on conventional insulin injection therapy, enabling precise insulin administration in home and hospital settings.

• How is the Disetronic H-Tronplus Insulin Infusion Pump supplied and intended for use?

  The device is supplied as a reusable infusion pump system intended for use in general hospital and home care settings, allowing repeated use under physician guidance for insulin delivery in both clinical and domestic environments.

• What regulatory pathway was used for the Disetronic H-Tronplus Insulin Infusion Pump?

  The Disetronic H-Tronplus Insulin Infusion Pump was cleared through the FDA 510(k) process under submission K023471, demonstrating substantial equivalence to a legally marketed predicate device for its intended use as a Class II medical device.