510(k) · Cleared
ClearedBlood 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 Dec 7, 2012 as substantially equivalent to K110017 (Andon Medical Co., Ltd., 2012) after a 263-day review. Its family tree reaches back 4 generations to 2003. 7 later devices descend from it.
- Decided
- Dec 7, 2012
- Review
- 263 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024194 (2003). 7 later devices descend from it, 2 citing it directly.
- 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 deviceK120813 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 · cites it directly · 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
- Descendant · 4 generations on · 0 of its ownK181070 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly2descendants
- K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd. · 2017 · 3 generations on1descendant
- K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd. · 2019 · 4 generations on0descendants
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) | 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 | — |
| +1 | 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 | — |
| +4 | K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | Andon Health Co, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K110017 | AG-608N Blood Glucose Monitoring SystemSummary page 1…evice information Manufacturer: Andon Medical Co., Ltd. Device: AG-608N Single Blood Glucose Monitoring System 510(k) number: k<110017 5- 1… | 2012 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 ancestors has a recall of any class.
- Of its descendants, K123935 (Andon Medical Co., Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 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. 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?
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for: * quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh * single person measurement only and should not be shared * 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 iHealth 6G3 Smart Gluco-Monitoring…
Read the full statement (148 words)
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
* quantitative measurement of glucose in fresh capillary whole blood samples
drawn from the fingertip, palm, forearm, upper arm, calf or thigh
* single person measurement only and should not be shared
* 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 iHealth 6G3 Smart Gluco-Monitoring System should not be used for the
diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when
glucose levels are not changing rapidly.
The AGS1 0001 test strips are intended for use with the iHealth BG3 meter to
quantitatively measure glucose in fresh capillary whole blood samples drawn from
the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120813: 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/K120813
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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