510(k) · Cleared
ClearedAmigo Insulin Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Diabetes Systems, Inc. · LZG Pump, Infusion, Insulin
Cleared on May 9, 2005 as substantially equivalent to K013309 (Nipro Diabetes Systems, Inc., 2002) after a 90-day review. Its family tree reaches back 3 generations to 1990. 1 of the 17 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- May 9, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901588 (1990). 5 ancestors in all. 11 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 2 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 1 generation backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- This deviceK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 4 generations on · 4 of its ownK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111210 T:Slim (TM) Insulin Delivery System2 generations on · 2011
Most influential descendants
Showing 5 of 11 · See all- K071613Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007 · cites it directly10descendants
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 2 generations on9descendants
- K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 3 generations on8descendants
- K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 3 generations on7descendants
- K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −2 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −1 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| 0 (this device) | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| +1 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| +2 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| +3 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +3 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +4 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 1 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K013309 | Glucopro Evo Infusion PumpSummary page 2…tended use, operating principle, overall design, performance, technology, features, functions, and materials to the GlucoPro EVA Pump as described in K013309. Amigo Insulin Pump GlucoPro EVA… | 2002 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071613 | Amigo Insulin Pump | 2007 | 10 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K071613 (Nipro Diabetes Systems, Inc., 2007) has gone furthest, with 10 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 Amigo Infusion Pump is intended for the subcutaneous infusion of insulin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050312: Amigo Insulin Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050312
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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