510(k) · Cleared
Recalled · 2009EZ Manager Max Diabetes Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · MRZ Accessories, Pump, Infusion
Cleared on May 15, 2008 as substantially equivalent to K063674 (Animas Corp., 2007) after a 73-day review. Its family tree reaches back 2 generations to 2003. It has been recalled once.
- Decided
- May 15, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022394 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022394 | Ezmanager Plus | Animas Corp. | 2003 | — |
| −1 | K063674 | Ezmanager Max Diabetes Management Software | Animas Corp. | 2007 | — |
| 0 (this device) | K080587 | EZ Manager Max Diabetes Management Software | Animas Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063674 | Ezmanager Max Diabetes Management SoftwareSummary page 1…e patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information. Predicate Device: K063674 - Animas ezManager ® Plus Diabetes Management Software (Animas Corporation) Substantial Equivalence: The Animas ezManager MAX is… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2009 | Not classified | Z-0481-2010 | Software design | Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080587: EZ Manager Max Diabetes Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080587
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026