510(k) · Cleared
Recalled · 2006Modification to D-Tronplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems AG · LZG Pump, Infusion, Insulin
Cleared on Dec 1, 2004 as substantially equivalent to K022831 (Disetronic Medical Systems AG, 2002) after a 30-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 1, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K905693 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 4 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- 3 generations backK994186 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems · 1999
- 2 generations backK021725 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems AG · 2002
- 1 generation backK022831 Modification to Disetronic D-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG · 2002 · Recalled
- This deviceK043000 Modification to D-TronplusDisetronic Medical Systems AG · 2004
- Descendant · cites it directly · 2 of its ownK100567 Pearl Diabetes Management SystemM2 Group Holdings, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK122483 Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK142619 Snap Insulin Pump SystemAsante Solutions, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −5 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −4 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| −3 | K994186 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems | 1999 | — |
| −2 | K021725 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
| −1 | K022831 | Modification to Disetronic D-Tronplus Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | 1 |
| 0 (this device) | K043000 | Modification to D-Tronplus | Disetronic Medical Systems AG | 2004 | — |
| +1 | K100567 | Pearl Diabetes Management System | M2 Group Holdings, Inc. | 2011 | — |
| +2 | K122483 | Pearl Diabetes Management System | Asante Solutions, Inc. | 2013 | — |
| +3 | K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K022831 | Modification to Disetronic D-Tronplus Insulin Infusion Pump | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100567 | Pearl Diabetes Management System | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2006 | Not classified | Z-1413-06 | Other | The battery may turn the pump off without warning due to a design change in the battery. |
| Jul 15, 2005 | Not classified | Z-1105-05 | Other | The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K100567 (M2 Group Holdings, Inc., 2011) 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 Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Dlabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin…
Read the full statement (114 words)
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.
It is indicated for patients with insulin dependent Dlabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043000: Modification to D-Tronplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043000
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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