# K080587: EZ Manager Max Diabetes Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: May 15, 2008 after 73 days
- Product code: MRZ (Accessories, Pump, Infusion)
- 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
Longest line of descent: 2 generations back to K022394 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063674: Ezmanager Max Diabetes Management Software, Animas Corp. (2007) Summary page 1.

## Recalls of this device
- Nov 2, 2009 · Not classified · Z-0481-2010: Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.

## Indications for use
The Animas ezManager ® MAX 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 healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

Source page: https://510kreport.com/device/K080587
Methodology: https://510kreport.com/methodology