510(k) · Cleared
ClearedBlood Glucose Monitoring System, Models AG-6081 and AG-6951
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 Aug 9, 2011 as substantially equivalent to K073030 (Andon Health Co, Ltd., 2008) after a 456-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Aug 9, 2011
- Review
- 456 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024194 (2003). 1 later device descends 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 deviceK101307 Blood Glucose Monitoring System, Models AG-6081 and AG-6951Andon Medical Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK120921 Clever ChoiceSimple Diagnostics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120921Clever ChoiceSimple Diagnostics, Inc. · 2012 · cites it directly0descendants
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) | K101307 | Blood Glucose Monitoring System, Models AG-6081 and AG-6951 | Andon Medical Co., Ltd. | 2011 | — |
| +1 | K120921 | Clever Choice | Simple Diagnostics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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…0 Predict device information Manufacturer: Andon Health Co., Ltd. Device: AG-606 Blood Glucose Monitoring System 510(k) number: k073030 5.0 Intended use 5.1 AG-6081 Single and AG-6951 Single BGMS The AG-6081 Single Blood Glucose Monitoring System is intende… | 2008 |
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 |
|---|---|---|---|
| K120921 | Clever Choice | 2012 | 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 8 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, K120921 (Simple Diagnostics, Inc., 2012) has gone furthest, with 0 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. 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?
The AG-6081 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared. The AG-6081 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)…
Read the full statement (906 words)
The AG-6081 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6081 Single Blood Glucose Monitoring System 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 AG-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.
The AG-6081 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.
The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.
The AG-6951 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6951 Single Blood Glucose Monitoring System 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 AG-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AG-6951 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.
The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101307: Blood Glucose Monitoring System, Models AG-6081 and AG-6951.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101307
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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