510(k) · Cleared
ClearediHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Sep 15, 2017 as substantially equivalent to K153278 (Andon Health Co, Ltd., 2016) after a 233-day review. Its family tree reaches back 7 generations to 2003. 1 later device descends from it.
- Decided
- Sep 15, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K024194 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 6 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 5 generations backK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- 4 generations backK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- 3 generations backK120813 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- 2 generations backK123935 Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013
- 1 generation backK153278 Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016
- This deviceK170231 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart…Andon Health Co, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK181070 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −6 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −5 | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… | Andon Medical Co., Ltd. | 2010 | — |
| −4 | K110017 | AG-608N Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| −3 | 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 | — |
| −1 | K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | 2016 | — |
| 0 (this device) | K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart… | Andon Health Co, Ltd. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153278 | Wireless Smart Gluco-Monitoring SystemSummary page 4…ion Manufacturer: Andon Health Co., Ltd. Device: iHealth® BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM 510(k) number: K153278 6-1 iHealth BG5, BG1 Smart Gluco-Monitoring System FDA 510(k) Fi… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | 2019 | 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 14 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K181070 (Andon Health Co, Ltd., 2019) has gone furthest, with 0 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. 2017, 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 iHealth® Align Gluco-Monitoring System (BG1) consists of the iHealth® Align Glucose meter (BG1), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application as the display component of the iHealth® Align Gluco-Monitoring System. The iHealth® Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip…
Read the full statement (319 words)
The iHealth® Align Gluco-Monitoring System (BG1) consists of the iHealth® Align Glucose meter (BG1), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application as the display component of the iHealth® Align Gluco-Monitoring System. The iHealth® Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth® Align Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth® Align Gluco-Monitoring System (BG1) 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 iHealth® Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The iHealth® Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth® Wireless Glucose meter (BG5), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application. The iHealth® Wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth® Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth® Wireless Smart Gluco-Monitoring System (BG5) 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 iHealth® Wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170231: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170231
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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