Model IR 1200 Insulin Pump

• • Terminated Z-0836-2013 FDA Class III ·initiated 17 Dec 2012

  Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.

• • Terminated Z-0005-2013 FDA Class II ·initiated 16 Jul 2012

  Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.

• • Terminated Z-1678-2011 FDA Unclassified (pre-2012) ·initiated 25 Feb 2011

  Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.

• • Terminated Z-2396-2010 FDA Unclassified (pre-2012) ·initiated 18 Mar 2010

  sensor could be damaged

• • Terminated Z-0293-2009 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008

  Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.

• • Terminated Z-0308-06 FDA Unclassified (pre-2012) ·initiated 31 Oct 2005

  Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

• • Terminated Z-0211-05 FDA Unclassified (pre-2012) ·initiated 28 Sep 2004

  Suspend mode not functioning properly

510(k) Number

K032257 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ez Set Infusion Set

  Class II

  FDA 510(k) K012754 Active Cleared 27 Aug 2001

• Ezmanager Max Diabetes Management Software

  Class II

  FDA 510(k) K063674 Active Cleared 30 Mar 2007

• R1000 Series Insulin Pump

  Class II

  FDA 510(k) K993184 Active Cleared 10 Feb 2000

• Ez Manager Max Diabetes Management Software

  Class II

  FDA 510(k) K080587 Active Cleared 15 May 2008

• Symphony Glucose Management System

  Class II

  FDA 510(k) K080639 Active Cleared 24 Jun 2008

• Animas Model IR1250 Insulin Infusion Pump

  Class II

  FDA 510(k) K042873 Active Cleared 10 Dec 2004

See all devices from Animas Corp. →

• What is the Animas IR 1200 Insulin Pump used for?

  The Animas IR 1200 Insulin Pump is an external syringe pump intended for subcutaneous insulin delivery. It is specifically designed for patients with diabetes mellitus who require continuous insulin infusion to manage their blood glucose levels. By administering insulin via an infusion set, it provides automated and precise dosing to help maintain stable glucose control.

• Is the Animas IR 1200 Insulin Pump single-use or reusable?

  The Animas IR 1200 Insulin Pump is supplied as a reusable medical instrument. It is intended for use in general hospital settings, where multiple patients may require insulin infusion therapy over time. Reusability is supported by proper handling, cleaning, and maintenance as outlined in the device’s instructions.

• What are the key specifications for storage and handling of the Animas IR 1200?

  The Animas IR 1200 must be stored and handled according to the manufacturer’s instructions to ensure safety and functionality. Unlike single-use devices, it requires regular maintenance, including cleaning and inspection, to prevent contamination or malfunctions. Additionally, the device is not intended for use in MRI environments, so proper storage away from magnetic fields is recommended.

• What regulatory status does the Animas IR 1200 Insulin Pump hold?

  The Animas IR 1200 Insulin Pump holds an FDA 510(k) clearance, classified as a Class II device. This clearance is based on substantial equivalence to the Animas IR 1000 Series Insulin Infusion Pump, meaning it meets the same regulatory standards for safety and performance. The device was reviewed by the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee (HO) and is approved for use in general hospital settings.

• Does the Animas IR 1200 come with any sterility guarantees?

  The regulatory data for the Animas IR 1200 Insulin Pump does not specify any sterility requirements or guarantees. Since it is a reusable device, sterility is maintained through proper cleaning and maintenance procedures as directed by the manufacturer. Clinicians should follow the included instructions to ensure the device remains safe for repeated use.