# K032257: Model IR 1200 Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Oct 16, 2003 after 86 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 2 cite it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Animas IR 1000 Series Insulin Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K042887: Accu-Chek Spirit (2005), 39 descendants of its own
- K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa (2006), 38 descendants of its own
- K111353: Accu-Check Combo System (2012), 37 descendants of its own
- K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own

## Recalls of this device
- Dec 17, 2012 · Class III · Z-0836-2013: 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.
- Jul 16, 2012 · Class II · Z-0005-2013: Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.
- Feb 25, 2011 · Not classified · Z-1678-2011: 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 car
- Mar 18, 2010 · Not classified · Z-2396-2010: sensor could be damaged
- Aug 4, 2008 · Not classified · Z-0293-2009: 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
- Oct 31, 2005 · Not classified · Z-0308-06: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Sep 28, 2004 · Not classified · Z-0211-05: Suspend mode not functioning properly

## Indications for use
The Animas Model Model IR 1200 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

Source page: https://510kreport.com/device/K032257
Methodology: https://510kreport.com/methodology