# K063674: Ezmanager Max Diabetes Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Mar 30, 2007 after 109 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
Longest line of descent: 1 generation back to K022394 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022394: Ezmanager Plus, Animas Corp. (2003) Summary page 1.
- K062323: Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817, Smiths Medical MD, Inc. (2006) Summary page 1.

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

## Indications for use
The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information. The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.

Source page: https://510kreport.com/device/K063674
Methodology: https://510kreport.com/methodology