510(k) · Cleared
ClearedAG-608 Blood Glucose Monitoring System and AG-610 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 Jul 13, 2010 as substantially equivalent to K073030 (Andon Health Co, Ltd., 2008) after a 267-day review. Its family tree reaches back 2 generations to 2003. 11 later devices descend from it.
- Decided
- Jul 13, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024194 (2003). 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 1 generation backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- This deviceK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- Descendant · cites it directly · 10 of its ownK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK120813 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- Descendant · 2 generations on · 3 of its ownK123935 Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK153278 Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK133790 Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110017AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012 · cites it directly10descendants
- K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012 · 2 generations on7descendants
- K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013 · 2 generations on3descendants
- K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016 · 3 generations on2descendants
- K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −1 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| 0 (this device) | 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 | — |
| +2 | K120813 | Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| +2 | K123935 | Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System | Andon Medical Co., Ltd. | 2013 | — |
| +3 | K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | 2016 | — |
| +3 | K133790 | Ihealth Align Mini Gluco-Monitoring System | Andon Health Co, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K073030 | AG-605 Blood Glucose Monitoring SystemSummary page 1…Clinical Chemistry 4.0 Predict device information Manufacturer: Andon Health Co., Ltd. Device: AG-606 Blood Glucose Monitoring System 510(k) number: k073030 5.0 Device description AG-608, AG-610 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, lancets,… | 2008 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110017 | AG-608N Blood Glucose Monitoring System | 2012 | 10 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K110017 (Andon Medical Co., Ltd., 2012) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K073030.
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. 2010, 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?
AG-608, AG-610 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger only. Testing is done outside the body (InVitro diagnostic use). It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093262: AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093262
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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