510(k) · Cleared
ClearedFreestyle Aviator Insulin Delivery and Blood Glucose Monitoring System
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 Feb 20, 2009 as substantially equivalent to K080639 (Animas Corp., 2008) and 3 other predicates after a 109-day review. Its family tree reaches back 9 generations to 1995. 1 of the 43 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 20, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K945887 (1995). 42 ancestors in all, the oldest K896951 (1990). No later device cites it as a predicate yet. 1 of the 43 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations between
- 3 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 2 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 1 generation backK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- This deviceK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009
Show all 9 generations
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 8 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 7 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 6 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 5 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 4 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 3 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 2 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 1 generation backK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- This deviceK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump2 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −8 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −7 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −6 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −5 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −4 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −3 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −2 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| −1 | K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2007 | 1 |
| 0 (this device) | K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 1 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K080639 | Symphony Glucose Management SystemSummary page 1…Class II: LFR, 21 CFR 862.1345 Substantially Equivalent Devices: Symphony Glucose Management System, K080639 iXL-II Diabetes Management System with Blood Glucose… | 2008 |
| * | K042792 | Ixl-II Diabetes Management SystemSummary page 1…lucose Management System, K080639 iXL-II Diabetes Management System with Blood Glucose Meter, K042792 Aviator Insulin Pump, K071788 FreeStyle Lite Blood, K… | 2005 |
| * | K071788 | Aviator Insulin PumpSummary page 1…iXL-II Diabetes Management System with Blood Glucose Meter, K042792 Aviator Insulin Pump, K071788 FreeStyle Lite Blood, K070850 Device Description The FreeStyle Avia… | 2008 |
| * | K070850 | Freestyle Lite Blood Glucose Monitoring SystemSummary page 1…Meter, K042792 Aviator Insulin Pump, K071788 FreeStyle Lite Blood, K070850 Device Description The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System consists… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 42 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K080639.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083225 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083225
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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