# K042873: Animas Model IR1250 Insulin Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Dec 10, 2004 after 53 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 3 cite it directly.
2 of 32 devices in its family (counting itself) have 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 Model IR1200 Insulin Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K061110: Glucommander Plus (2006), 16 descendants of its own
- K101344: G+ System (2010), 13 descendants of its own
- K113853: G+ System (2012), 12 descendants of its own
- K071613: Amigo Insulin Pump (2007), 10 descendants of its own
- K111210: T:Slim (TM) Insulin Delivery System (2011), 9 descendants of its own

## Recalls of this device
- Jan 3, 2013 · Class I · Z-0993-2013: Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the 
- 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.
- Aug 4, 2008 · Not classified · Z-0294-2009: 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
- Aug 4, 2008 · Not classified · Z-0292-2009: 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-0309-06: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Apr 11, 2005 · Not classified · Z-0929-05: pump failed to respond to keypad button pressess after using the food database feature

## Indications for use
The Animas Model IR1250 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.

Source page: https://510kreport.com/device/K042873
Methodology: https://510kreport.com/methodology