510(k) · Cleared
ClearedIhealth Align Mini Gluco-Monitoring System
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 May 22, 2014 as substantially equivalent to K120813 (Andon Medical Co., Ltd., 2012) after a 164-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- May 22, 2014
- Review
- 164 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K024194 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 4 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 3 generations backK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- 2 generations backK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- 1 generation backK120813 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- This deviceK133790 Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK153286 iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK150833 iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart…Andon Health Co, Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −4 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −3 | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… | Andon Medical Co., Ltd. | 2010 | — |
| −2 | K110017 | AG-608N Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| −1 | K120813 | Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| 0 (this device) | K133790 | Ihealth Align Mini Gluco-Monitoring System | Andon Health Co, Ltd. | 2014 | — |
| +1 | K153286 | iHealth Align Gluco-Monitoring system | Andon Health Co, Ltd. | 2016 | — |
| +1 | K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart… | Andon Health Co, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K120813 | Blood Glucose Monitoring SystemSummary page 2…icate device information Manufacturer: Andon Health Co., Ltd. Device: iHealth BG3 Smart Gluco-Monitoring System 510(k) number: k<120813 5.0 Device description The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use te… | 2012 |
What descends from it? (2)
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 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K153286 (Andon Health Co, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120813.
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 iHealth Align Gluco-Monitoring system (BG1) 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 system should not…
Read the full statement (150 words)
The iHealth Align Gluco-Monitoring system (BG1) 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 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.
iHealth Blood Glucose Test Strips (AGS-10001) are intended for use with the iHealth Align Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133790 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133790: Ihealth Align Mini Gluco-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/K133790
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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