510(k) · Cleared
Recalled · 2003Disetronic H-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 Oct 29, 2002 as substantially equivalent to K973044 (Disetronic Medical Systems, 1997) after a 14-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Oct 29, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905693 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 1 generation backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- This deviceK023471 Disetronic H-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −1 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| 0 (this device) | K023471 | Disetronic H-Tronplus Insulin Infusion Pump | Disetronic Medical Systems AG | 2002 | — |
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 |
|---|---|---|---|
| * | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion PumpSummary page 1…Substantial Equivalence The modified H-TRONplus Insulin Infusion Pump is substantially equivalent to H-TRONplus Insulin Infusion Pump, K973044. Device Description The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, bat… | 1997 |
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 |
|---|---|---|---|---|
| Jul 21, 2003 | Not classified | Z-1197-03 | Other | Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water. |
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 6.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K973044.
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 H-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 (113 words)
The Disetronic H-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/K023471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023471: Disetronic H-Tronplus Insulin Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023471
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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