510(k) · Cleared
ClearedIdeal Life Gluco-Manager Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ideal Life, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 25, 2014 as substantially equivalent to K110017 (Andon Medical Co., Ltd., 2012) after a 345-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Jun 25, 2014
- Review
- 345 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 3 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 2 generations backK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- 1 generation backK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- This deviceK132180 Ideal Life Gluco-Manager Blood Glucose Monitoring SystemIdeal Life, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −3 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −2 | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… | Andon Medical Co., Ltd. | 2010 | — |
| −1 | K110017 | AG-608N Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| 0 (this device) | K132180 | Ideal Life Gluco-Manager Blood Glucose Monitoring System | Ideal Life, Inc. | 2014 | — |
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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 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 |
|---|---|---|---|
| * | K110017 | AG-608N Blood Glucose Monitoring SystemSummary page 1…redicate Device Information Manufacturer: Andlon Medical Co., Ltd. Device: AG-608N Single Blood Glucose Monitoring System 510(k) Number: K110017 5. Device Description The IDEAL LIFE Gluco-Manager m Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucos… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K110017.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared. The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended for self-testing…
Read the full statement (315 words)
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.
The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.
The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the glucose meter and test strips are working properly and that the measurement is accurate.
The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.
The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132180 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132180: Ideal Life Gluco-Manager 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/K132180
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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