# K022394: Ezmanager Plus

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Jun 5, 2003 after 317 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Minimed Solutions Software, Model 7311: named in the summary without a submission number
- (no number) Therasense Freestyle Tracker Diabetes Management System: named in the summary without a submission number

## Most influential descendants
- K063674: Ezmanager Max Diabetes Management Software (2007), 1 descendant of its own
- K080587: EZ Manager Max Diabetes Management Software (2008), 0 descendants of its own

## Indications for use
The Animas ezManager Plus is indicated for use as an accessory to the Animas IRIOOO insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient’s or a physician’s personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.

Source page: https://510kreport.com/device/K022394
Methodology: https://510kreport.com/methodology