# K993184: R1000 Series Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Feb 10, 2000 after 140 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 no predicate by number.

## Recalls of this device
- Oct 31, 2005 · Not classified · Z-0306-06: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

## Indications for use
The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the 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/K993184
Methodology: https://510kreport.com/methodology