510(k) · Cleared
ClearedAndon Health Care Management System Software
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 Sep 30, 2011 as substantially equivalent to K102678 (Andon Medical Co., Ltd., 2011) after a 10-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Sep 30, 2011
- Review
- 10 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001907 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 2 generations backK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
- 1 generation backK102678 Andon Health Care Management System Software, AG-608 Single & AG-608…Andon Medical Co., Ltd. · 2011
- This deviceK112738 Andon Health Care Management System SoftwareAndon Medical Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −2 | K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | 2007 | — |
| −1 | K102678 | Andon Health Care Management System Software, AG-608 Single & AG-608 Multi… | Andon Medical Co., Ltd. | 2011 | — |
| 0 (this device) | K112738 | Andon Health Care Management System Software | Andon Medical Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K102678 | Andon Health Care Management System Software, AG-608 Single & AG-608 Multi Blood Glucose…Summary page 4…he predict device and the conclusion Andon Health Care Management System Software is very similar with the predicted device Andon Health Care Management System Software(K102678), However, they are intended to use together with 4 additional BGMS: AG-6081 Single Blood Glucose Monitoring System and AG-6081 M… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 4.2 years on median.
- None of the 3 ancestors has a recall.
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. 2011, 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?
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from. the device's memory into a computer for enhanced data management. Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with…
Read the full statement (138 words)
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from. the device's memory into a computer for enhanced data management.
Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112738: Andon Health Care Management System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112738
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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