510(k) · Cleared
ClearedDiabetes Data Management System (DDMS), Model 7333
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · LZG Pump, Infusion, Insulin
Cleared on Oct 23, 2003 after a 100-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 23, 2003
- Review
- 100 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK032164 Diabetes Data Management System (DDMS), Model 7333Medtronic Minimed · 2003
- Descendant · cites it directly · 2 of its ownK101806 Aidera Diasend SystemAidera AB · 2010
- Descendant · 2 generations on · 0 of its ownK132618 Onetouch RevealLifescan, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122361 T:Connect Data Management SystemTandem Diabetes Care, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032164 | Diabetes Data Management System (DDMS), Model 7333 | Medtronic Minimed | 2003 | — |
| +1 | K101806 | Aidera Diasend System | Aidera AB | 2010 | — |
| +2 | K132618 | Onetouch Reveal | Lifescan, Inc. | 2013 | — |
| +1 | K122361 | T:Connect Data Management System | Tandem Diabetes Care, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Medtronic MiniMed Solutions Pumps and Meter software, model 7311 Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K101806 (Aidera AB, 2010) has gone furthest, with 2 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.
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 Medtronic MiniMed Diabetes Data Management System (DDMS) is a service intended to facilitate the review and analysis of information downloaded from Medtronic MiniMed insulin inhsion pumps and compatible home glucose meters. Information downloaded to or entered into a PC is transmitted via the Internet to a Medtronic MiniMed database. DDMS includes numerous options for the analysis and display of this information. The displays and reports available in DDMS may be useful in identifying the impact of insulin delivery, daily activities and diet on glucose control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032164: Diabetes Data Management System (DDMS), Model 7333.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032164
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