510(k) · Cleared
ClearedSolusmobile Blood Glucose Managment 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 Jun 28, 2013 as substantially equivalent to K093764 (Biotest Medical Corp., 2010) after a 221-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Jun 28, 2013
- Review
- 221 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042005 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
- 4 generations backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
- 3 generations backK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
- 2 generations backK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
- 1 generation backK093764 SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp. · 2010
- This deviceK123559 Solusmobile Blood Glucose Managment SystemBiotest Medical Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 | Taidoc Technology Corporation | 2004 | — |
| −4 | K060467 | Prodigy Blood Glucose Test System | Diagnostic Devices, Inc. | 2006 | — |
| −3 | K073118 | Prodigy Voice Blood Glucose Monitoring System | Diagnostic Devices, Inc. | 2008 | — |
| −2 | K091815 | Supercheck 1 Blood Glucose Monitoring System, Model 6268 | Biotest Medical Corp. | 2009 | — |
| −1 | K093764 | SOLOV2 Blood Glucose Monitoring System | Biotest Medical Corp. | 2010 | — |
| 0 (this device) | K123559 | Solusmobile Blood Glucose Managment System | 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 |
|---|---|---|---|
| * | K093764 | SOLOV2 Blood Glucose Monitoring SystemSummary page 1…Name: SOLO V2 Blood Glucose Management System (Model 6131) Common Name: In Vitro Diagnostic Glucose Test System Submitter: Biotest Medical Corporation 510(k) Number: K093764 4. Device Description The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose Page 1 of 5 K1… | 2010 |
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 1.7 years on median.
- None of the 5 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. 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?
SOLUSmobile Blood Glucose Management System (Model 6134) The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or…
Read the full statement (252 words)
SOLUSmobile Blood Glucose Management System (Model 6134)
The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or screening for diabetes mellitus, nor for use in neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains an audible readout function that provides an audible message of test resuits for users. The SOLUSmobile Blood Glucose Management System uses cellular data transmission to send test results to a cloud server, Telemed-Gluconet.
SOLUSmobile Blood Glucose Test Strips
The SOLUSmobile Blood Glucose Test Strips are to be used with the SOLUSmobile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood from the finger and the forearm. These test strips are intended for use by a single patient with diabetes mellitus at home and should not be shared.
SOLUSmobile Control Solutions
The SOLUSmobile Control Solutions are for use with SOLUSMobile Meter and Test Strips to check that the meters and test strips are working together properly and that the test is performing correction. A control test that falls within the stated range indicates the user technique is appropriate and the test strip and meter are functioning properiy.
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/K123559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123559: Solusmobile Blood Glucose Managment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123559
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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