510(k) · Cleared
ClearedAviator Insulin Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · LZG Pump, Infusion, Insulin
Cleared on Jan 11, 2008 as substantially equivalent to K051041 (Abbott Diabetes Care, Inc., 2005) after a 193-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jan 11, 2008
- Review
- 193 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040676 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040676 Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715Medtronic Minimed · 2004 · Recalled
- 1 generation backK051041 Insulin PumpAbbott Diabetes Care, Inc. · 2005
- This deviceK071788 Aviator Insulin PumpAbbott Diabetes Care, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040676 | Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715 | Medtronic Minimed | 2004 | 2 |
| −1 | K051041 | Insulin Pump | Abbott Diabetes Care, Inc. | 2005 | — |
| 0 (this device) | K071788 | Aviator Insulin Pump | Abbott Diabetes Care, Inc. | 2008 | — |
| +1 | K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K051041 | Insulin PumpSummary page 1…Insulin Infusion Pump (LZG) 21 CFR 880.5725 Substantially Equivalent Device: Abbott Diabetes Care Insulin Pump, K051041 Device Description The Aviator insulin pump is a microprocessor controlled, battery powered, insulin pump system. The p… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K083225 (Abbott Diabetes Care, Inc., 2009) has gone furthest, with 0 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. 2008, 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 Aviator Insulin Pump is indicated for continuous delivery of insulin, at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071788: Aviator 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/K071788
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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