510(k) · Cleared
Recalled · 2003Modification to Disetronic D-Tronplus Insulin Infusion Pump
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 Sep 11, 2002 as substantially equivalent to K994186 (Disetronic Medical Systems, 1999) and 1 other predicate after a 16-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K905693 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 3 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- 2 generations backK994186 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems · 1999
- 1 generation backK021725 Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems AG · 2002
- This deviceK022831 Modification to Disetronic D-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG · 2002
- Descendant · cites it directly · 3 of its ownK043000 Modification to D-TronplusDisetronic Medical Systems AG · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK100567 Pearl Diabetes Management SystemM2 Group Holdings, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK122483 Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK142619 Snap Insulin Pump SystemAsante Solutions, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K043000Modification to D-TronplusDisetronic Medical Systems AG · 2004 · cites it directly3descendants
- K100567Pearl Diabetes Management SystemM2 Group Holdings, Inc. · 2011 · 2 generations on2descendants
- K122483Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013 · 3 generations on1descendant
- K142619Snap Insulin Pump SystemAsante Solutions, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −3 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| −2 | K994186 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems | 1999 | — |
| −1 | K021725 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
| 0 (this device) | K022831 | Modification to Disetronic D-Tronplus Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
| +1 | K043000 | Modification to D-Tronplus | Disetronic Medical Systems AG | 2004 | 2 |
| +2 | K100567 | Pearl Diabetes Management System | M2 Group Holdings, Inc. | 2011 | — |
| +3 | K122483 | Pearl Diabetes Management System | Asante Solutions, Inc. | 2013 | — |
| +4 | K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K994186 | Disetronic D-Tron Insulin Infusion PumpSummary page 1…Substantial Equivalence The D-TRONplus Insulin Infusion Pump is substantially equivalent to the currently marketed D-TRON Insulin Infusion Pump K994186 / K021725. Device Description The Disetronic D-TRONplus Insulin Pump is an ambulatory, ba… | 1999 |
| * | K021725 | Disetronic D-Tron Insulin Infusion PumpSummary page 1…Substantial Equivalence The D-TRONplus Insulin Infusion Pump is substantially equivalent to the currently marketed D-TRON Insulin Infusion Pump K994186 / K021725. Device Description The Disetronic D-TRONplus Insulin Pump is an ambulatory, battery oper… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043000 | Modification to D-Tronplus | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2003 | Not classified | Z-1198-03 | Other | Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K043000 (Disetronic Medical Systems AG, 2004) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K994186.
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 Diabetes 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 Diabetes 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 professional experienced in insulin pump therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022831: Modification to Disetronic D-Tronplus Insulin Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022831
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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