510(k) · Cleared
Recalled · 2004Disetronic H-Tron Plus V 100 Insulin Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems · LZG Pump, Infusion, Insulin
Cleared on Sep 15, 1997 as substantially equivalent to K905693 (Disetronic Medical Systems, 1991) after a 31-day review. Its family tree reaches back 1 generation to 1991. 1 of the 29 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 15, 1997
- Review
- 31 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905693 (1991). 27 later devices descend from it, 5 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- This deviceK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997
- Descendant · cites it directly · 12 of its ownK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 11 of its ownK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- Descendant · 3 generations on · 10 of its ownK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- Descendant · 4 generations on · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- Descendant · 5 generations on · 8 of its ownK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111210 T:Slim (TM) Insulin Delivery System4 generations on · 2011
Most influential descendants
Showing 5 of 27 · See all- K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · cites it directly12descendants
- K050312Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005 · 2 generations on11descendants
- K071613Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007 · 3 generations on10descendants
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 4 generations on9descendants
- K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| 0 (this device) | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | — |
| +1 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| +2 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| +3 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| +4 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| +5 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K905693 | H-Tron V 100 Insulin Infusion PumpSummary page 1…mp 9.4 Substantial Equivalence: The Disetronic H-TRON Plus V 100 Insulin Infusion Pump is substantially equivalent to the Disetronic H-TRON V 100 Insulin Infusion Pump (K905693). 9.5 Device Description The physical dimensions and specifications, pumpmg method, safety systems, accuracy and basic design an… | 1991 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2004 | Not classified | Z-1225-04 | Other | Lack of assurance of sterility. |
| May 17, 2004 | Not classified | Z-1226-04 | Other | Lack of assurance of sterility. |
| May 17, 2004 | Not classified | Z-1222-04 | Other | Lack of assurance of sterility. |
| May 17, 2004 | Not classified | Z-1224-04 | Other | Lack of assurance of sterility. |
| May 17, 2004 | Not classified | Z-1223-04 | Other | Lack of assurance of sterility. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K013309 (Nipro Diabetes Systems, Inc., 2002) has gone furthest, with 12 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 H-TRON V 100 Plus 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, as well as adhere to a proper diet and exercise regiment. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973044: Disetronic H-Tron Plus V 100 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/K973044
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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