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 Dec 14, 2007 as substantially equivalent to K042873 (Animas Corp., 2004) and 2 other predicates after a 184-day review. Its family tree reaches back 4 generations to 1990. 2 of the 19 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 184 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K901588 (1990). 8 ancestors in all. 10 later devices descend from it, 1 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- 3 generations backK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
- 2 generations backK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
- 1 generation backK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
- This deviceK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK160056 t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016
- Descendant · 4 generations on · 2 of its ownK240158 Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · cites it directly9descendants
- K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 2 generations on8descendants
- K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 2 generations on7descendants
- K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2016 · 3 generations on4descendants
- K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| −3 | K960001 | Minimed Infusion Pump, Model MMT-507 | Medtronic Minimed | 1996 | — |
| −2 | K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | 2002 | 1 |
| −1 | K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2005 | — |
| 0 (this device) | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| +1 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| +2 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +2 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +3 | K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016 | — |
| +4 | K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 1 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have 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? (3)
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 |
|---|---|---|---|
| * | K042873 | Animas Model IR1250 Insulin Infusion PumpSummary page 1…1 CFR § 880.5725 Establishment registration: Nipro Diabetes Systems, Inc. #1 066380 Predicate device(s) Animas IR1250 Insulin Infusion Pump K042873 Nipro Amigo® Insulin Pump K050312 Smiths Medical Delt… | 2004 |
| * | K050312 | Amigo Insulin PumpSummary page 1…ystems, Inc. #1 066380 Predicate device(s) Animas IR1250 Insulin Infusion Pump K042873 Nipro Amigo® Insulin Pump K050312 Smiths Medical Deltec Cozmo® Insulin Pump K062323… | 2005 |
| * | K062323 | Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815…Summary page 1…Nipro Amigo® Insulin Pump K050312 Smiths Medical Deltec Cozmo® Insulin Pump K062323 02-0003… | 2006 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111210 | T:Slim (TM) Insulin Delivery System Class I | 2011 | 9 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 5 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K111210 (Tandem Diabetes Care, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K042873.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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® Insulin Pump is intended for the subcutaneous infusion of insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071613 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071613: Amigo Insulin Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071613
Report an extraction error
Are you the manufacturer?
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