# K021439: Model R1000 IR Insulin Pump, Ezlink Software, Sermon Software, R1000 IR Download Cradle, and Serial Interface Adaptor DO

- Pathway: 510(k) (Special)
- Applicant: Animas Corp.
- Decided: May 29, 2002 after 23 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 R1000 Series Insulin Infusion Pump: named in the summary without a submission number

## Recalls of this device
- Oct 31, 2005 · Not classified · Z-0307-06: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

## Indications for use
The Animas Model Model R1000 IR 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. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the “dongle”), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved. This device is intended for home use and is a prescription device.

Source page: https://510kreport.com/device/K021439
Methodology: https://510kreport.com/methodology