510(k) · Cleared
Recalled · 2012Symphony Glucose Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · LZG Pump, Infusion, Insulin
Cleared on Jun 24, 2008 as substantially equivalent to K042873 (Animas Corp., 2004) and 6 other predicates after a 110-day review. Its family tree reaches back 2 generations to 1995. 1 of the 12 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 24, 2008
- Review
- 110 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 7
- Predicates
- 7
Its longest line of descent runs back 2 generations to K950727 (1995). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 1 generation backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- This deviceK080639 Symphony Glucose Management SystemAnimas Corp. · 2008
- Descendant · cites it directly · 0 of its ownK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK082590 Symphony Meter RemoteLifescan, Inc. · 2008
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pumpdirect predicate · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −1 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| 0 (this device) | K080639 | Symphony Glucose Management System | Animas Corp. | 2008 | — |
| +1 | K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2009 | — |
| +1 | K082590 | Symphony Meter Remote | Lifescan, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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.
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? (7)
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…- Class II, One®Touch Ultra Test Strips, per 21 CFR § 862.1345 PREDICATE DEVICES: Animas® IR 1250 insulin pump (K042873) OneTouch® UltraSmart® Blood Glucose Monitoring System (K021819, K043197)… | 2004 |
| * | K021819 | One Touch Ultrasmart Blood Glucose Monitoring SystemSummary page 1…DICATE DEVICES: Animas® IR 1250 insulin pump (K042873) OneTouch® UltraSmart® Blood Glucose Monitoring System (K021819, K043197) OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529)… | 2002 |
| * | K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemSummary page 1…VICES: Animas® IR 1250 insulin pump (K042873) OneTouch® UltraSmart® Blood Glucose Monitoring System (K021819, K043197) OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529)… | 2005 |
| * | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemSummary page 1…Monitoring System (K021819, K043197) OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529) Medtronic MiniMed Paradigm Model 512 Insulin Pump and Paradigm Link Gluco… | 2006 |
| * | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterSummary page 1…System (K053529) Medtronic MiniMed Paradigm Model 512 Insulin Pump and Paradigm Link Glucose Meter (K03053 1, K040603) Insulet OmniPod iXL-II Diabetes Management… | 2003 |
| * | K040603 | Paradigm Link Blood Glucose MeterSummary page 1…Medtronic MiniMed Paradigm Model 512 Insulin Pump and Paradigm Link Glucose Meter (K03053 1, K040603) Insulet OmniPod iXL-II Diabetes Management System (K042792) Animas Corpor… | 2004 |
| * | K042792 | Ixl-II Diabetes Management SystemSummary page 1…nk Glucose Meter (K03053 1, K040603) Insulet OmniPod iXL-II Diabetes Management System (K042792) Animas Corporation Section 5- 510(k) Summary Page 1 of 3 Symphony System… | 2005 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Mar 1, 2012 | Not classified | Z-1376-2012 | Software design | There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not… |
| Mar 18, 2010 | Not classified | Z-2394-2010 | Equipment maintenance | sensor could be damaged |
| Dec 18, 2009 | Not classified | Z-1560-2010 | Software design | Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food… |
| Oct 27, 2008 | Not classified | Z-0955-2009 | Software design | incorrect dosing recommendation |
| Aug 4, 2008 | Not classified | Z-0290-2009 | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure… |
| Aug 4, 2008 | Not classified | Z-0291-2009 | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure… |
| Aug 4, 2008 | Not classified | Z-0283-2009 | Software design | display old, inaccurate values for bolus amount delivered and amount of planned bolus totals |
The 5 latest of 7 recalls; the web page lists all.
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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K083225 (Abbott Diabetes Care, Inc., 2009) has gone furthest, with 0 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. 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 Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood. The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to…
Read the full statement (144 words)
The Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood.
The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080639: Symphony Glucose Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080639
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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