510(k) · Cleared
ClearedClever Choice
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simple Diagnostics, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Aug 21, 2012 as substantially equivalent to K101307 (Andon Medical Co., Ltd., 2011) after a 147-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Aug 21, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 2 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 1 generation backK101307 Blood Glucose Monitoring System, Models AG-6081 and AG-6951Andon Medical Co., Ltd. · 2011
- This deviceK120921 Clever ChoiceSimple Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −2 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −1 | K101307 | Blood Glucose Monitoring System, Models AG-6081 and AG-6951 | Andon Medical Co., Ltd. | 2011 | — |
| 0 (this device) | K120921 | Clever Choice | Simple Diagnostics, Inc. | 2012 | — |
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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K101307 | Blood Glucose Monitoring System, Models AG-6081 and AG-6951Summary page 1…n Medical Co., Ltd. Device: AG-6951 Single Blood Glucose Monitoring System AG-6951 Multi Blood Glucose Monitoring System 510(k) number: K101307 5.0 Device description Clever Choice Voice+ S Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single u… | 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 9 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Clever Choice Voice+ S 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 Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S Blood Glucose Monitoring System is intended for self testing outside the body…
Read the full statement (904 words)
The Clever Choice Voice+ S 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 Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S 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 Clever Choice Voice+ S 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 Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice Voice+ S 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 Clever Choice 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 Clever Choice Voice+ S meters and Clever Choice +S Test Strips.
The Clever Choice Voice+ M 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 Clever Choice Voice+ M 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 Clever Choice Voice+ M 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 Clever Choice +M Blood Glucose Test Strips are for use with the Clever Choice+ M 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 Clever Choice 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 Clever Choice Voice+ M meters and Clever Choice +M Test Strips.
Only auto-disabling, single use lancing devices may be used with this device.
The Clever Choice+ S 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 Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The Clever Choice+ S 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 Clever Choice+ S 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 Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S 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 Clever Choice 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 Clever Choice+ S meters and Clever Choice +S Test Strips.
The Clever Choice Voice+ M 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 Clever Choice + M 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 Clever Choice Voice+ M 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 Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M 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 Clever Choice 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 Clever Choice+ M meters and Clever Choice +MTest Strips.
Only auto-disabling, single use lancing devices may be used with this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120921: Clever Choice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120921
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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