510(k) · Cleared
ClearedAG-608N Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Medical Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jan 18, 2012 as substantially equivalent to K093262 (Andon Medical Co., Ltd., 2010) after a 380-day review. Its family tree reaches back 3 generations to 2003. 10 later devices descend from it.
- Decided
- Jan 18, 2012
- Review
- 380 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). 10 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 2 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 1 generation backK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- This deviceK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- Descendant · cites it directly · 7 of its ownK120813 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK123935 Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK153278 Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK133790 Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK170231 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart…Andon Health Co, Ltd. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012 · cites it directly7descendants
- K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013 · cites it directly3descendants
- K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016 · 2 generations on2descendants
- K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd. · 2014 · 2 generations on2descendants
- K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −2 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −1 | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… | Andon Medical Co., Ltd. | 2010 | — |
| 0 (this device) | K110017 | AG-608N Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| +1 | K120813 | Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| +1 | K123935 | Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System | Andon Medical Co., Ltd. | 2013 | — |
| +2 | K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | 2016 | — |
| +2 | K133790 | Ihealth Align Mini Gluco-Monitoring System | Andon Health Co, Ltd. | 2014 | — |
| +3 | K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart… | Andon Health Co, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring SystemSummary page 3…MULTI Blood Glucose Monitoring System Monitoring System (K093262) Detection Method Amperometry Amperometry Enzyme… | 2010 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120813 | Blood Glucose Monitoring System | 2012 | 7 |
| K123935 | Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System | 2013 | 3 |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | 2017 | 0 |
| K132180 | Ideal Life Gluco-Manager Blood Glucose Monitoring System | 2014 | 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 9 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120813 (Andon Medical Co., Ltd., 2012) has gone furthest, with 7 descendants of its own.
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. 2012, 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 AG-608N Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in…
Read the full statement (432 words)
The AG-608N Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-608N single Blood Glucose Monitoring System 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 AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-iQOOON single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.
The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices.
The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-100ON MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110017: AG-608N 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/K110017
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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