H-Tron V 100 Insulin Infusion Pump

• • Terminated Z-1196-03 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

K905693 ↗

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 H-Tron V 100 Insulin Infusion Pump used for?

  The H-Tron V 100 Insulin Infusion Pump is designed for continuous, automated delivery of insulin to patients requiring precise glycemic control, particularly those with diabetes. It mimics basal and bolus insulin patterns through programmable dosing regimens, enhancing therapeutic management in hospital environments.

• Is the H-Tron V 100 a single-use or reusable device?

  The H-Tron V 100 is supplied as a reusable device. It requires proper handling, maintenance, and sterile conditions during clinical use to ensure patient safety and functionality.

• What regulatory clearance does the H-Tron V 100 hold?

  The H-Tron V 100 Insulin Infusion Pump holds FDA 510(k) clearance under the reference number K905693. It is classified as a Class II medical device and adheres to regulatory requirements for insulin infusion pumps, including product code LZG.

• How should the H-Tron V 100 be stored and handled?

  The H-Tron V 100 must be stored and handled according to standard medical device protocols to maintain functionality and ensure patient safety. Sterility is maintained during clinical use, and adherence to manufacturer instructions for maintenance is critical.

• What types of settings is the H-Tron V 100 intended for?

  This device is intended for use in general hospital settings, where precise insulin delivery is required for patients with diabetes or other conditions necessitating glycemic control.