Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do

• • Terminated Z-0307-06 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.

510(k) Number

K021439 ↗

FDA Product Code

LZG

Models / Variants

R1000 Ir Insulin Pump

Ezlink Software

Sermon Software

R1000 Ir Download Cradle

Serial Interface Adaptor Do

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

• Model IR 1200 Insulin Pump

  Class II

  FDA 510(k) K032257 Active Cleared 16 Oct 2003

• 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

See all devices from Animas Corp. →