510(k) · Cleared
ClearedSmartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotest Medical Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 2, 2013 as substantially equivalent to K091815 (Biotest Medical Corp., 2009) after a 255-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- May 2, 2013
- Review
- 255 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042005 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
- 3 generations backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
- 2 generations backK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
- 1 generation backK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
- This deviceK122525 Smartest Glucowise Blood Glucose Monitoring System, and Smartest…Biotest Medical Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 | Taidoc Technology Corporation | 2004 | — |
| −3 | K060467 | Prodigy Blood Glucose Test System | Diagnostic Devices, Inc. | 2006 | — |
| −2 | K073118 | Prodigy Voice Blood Glucose Monitoring System | Diagnostic Devices, Inc. | 2008 | — |
| −1 | K091815 | Supercheck 1 Blood Glucose Monitoring System, Model 6268 | Biotest Medical Corp. | 2009 | — |
| 0 (this device) | K122525 | Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise… | Biotest Medical Corp. | 2013 | — |
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 |
|---|---|---|---|
| * | K091815 | Supercheck 1 Blood Glucose Monitoring System, Model 6268Summary page 2…The SmarteStTM Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the SmarteStiM SuperCheck I Blood Glucose Monitoring System (K09 1815). The SmartestTM Glucowise Blood Glucose Monitoring System has done a cleaning and disinfection validation test to comply with "… | 2009 |
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 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K091815.
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. 2013, 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 Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used by a single person and should not be shared. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended for self-testing…
Read the full statement (404 words)
The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used by a single person and should not be shared.
The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S 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 Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S 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 Smartest™ Glucowise Test Strips are for use with the Smartest™ Glucowise Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.
The Smartest™ Glucowise Control Solutions are for use with the Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S as a quality control check to verify that the meter and test strips are working together properly.
The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M 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 Smartest™ Glucowise MULTI Test Strips are for use with the Smartest™ Glucowise MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.
The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that the meter and test strips are working together properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122525: Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122525
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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