510(k) · Cleared
ClearedEzmanager Max Diabetes Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · LZG Pump, Infusion, Insulin
Cleared on Mar 30, 2007 as substantially equivalent to K022394 (Animas Corp., 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Mar 30, 2007
- Review
- 109 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022394 (2003). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K080587EZ Manager Max Diabetes Management SoftwareAnimas Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022394 | Ezmanager Plus | Animas Corp. | 2003 | — |
| 0 (this device) | K063674 | Ezmanager Max Diabetes Management Software | Animas Corp. | 2007 | — |
| +1 | K080587 | EZ Manager Max Diabetes Management Software | Animas Corp. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 LZG? 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 LZG device
- #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K022394 | Ezmanager PlusSummary page 1…N: Class II per CFR 21 §880.5725, Infusion Pump, product code LZG PREDICATE DEVICE: Animas ezManager Plus, K022394 Deltec, CoZmanager, K062323 DESCRIPTION: The Animas ezManager Plus diabetes m… | 2003 |
| * | K062323 | Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815…Summary page 1…ump, product code LZG PREDICATE DEVICE: Animas ezManager Plus, K022394 Deltec, CoZmanager, K062323 DESCRIPTION: The Animas ezManager Plus diabetes management system is software… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080587 | EZ Manager Max Diabetes Management Software | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K080587 (Animas Corp., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZG
116in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZG
1in 2022
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · LZG
12,004in 2025
MAUDE reports naming product code LZG, 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 | 3 | 112 | 1 | 5,110 |
| 2008 | 6 | 129 | 13 | 5,711 |
| 2009 | 2 | — | 2 | 9,471 |
| 2010 | 2 | — | 4 | 10,175 |
| 2011 | 4 | 189 | 2 | 12,858 |
| 2012 | 3 | 73 | 4 | 18,367 |
| 2013 | 2 | — | 3 (1) | 30,059 |
| 2014 | 4 | 123 | 2 (1) | 49,188 |
| 2015 | 1 | — | 2 (2) | 69,136 |
| 2016 | 4 | 116 | 0 | 56,581 |
| 2017 | 1 | — | 0 | 44,472 |
| 2018 | 1 | — | 3 (2) | 32,652 |
| 2019 | 2 | — | 5 | 29,027 |
| 2020 | 0 | — | 0 | 32,588 |
| 2021 | 1 | — | 0 | 31,522 |
| 2022 | 1 | — | 1 (1) | 28,225 |
| 2023 | 1 | — | 0 | 21,972 |
| 2024 | 2 | — | 0 | 18,228 |
| 2025 | 0 | — | 0 | 12,004 |
| 2026 | 2 | — | 2 (2) | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063674: Ezmanager Max Diabetes Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063674
Report an extraction error
Are you the manufacturer?
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