510(k) · Cleared
ClearedAutosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 14, 2015 as substantially equivalent to K102037 (Apex BioTechnology Corp., 2010) after a 238-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Oct 14, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102037 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK102037 Autosure Voice II Blood Glucose Monitoring System and Test StripsApex BioTechnology Corp. · 2010
- This deviceK150396 Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II…Apex BioTechnology Corp. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102037 | Autosure Voice II Blood Glucose Monitoring System and Test Strips | Apex BioTechnology Corp. | 2010 | — |
| 0 (this device) | K150396 | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood… | Apex BioTechnology Corp. | 2015 | — |
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 |
|---|---|---|---|
| * | K102037 | Autosure Voice II Blood Glucose Monitoring System and Test StripsSummary page 5…ss II Product Codes CGA, NBW Predicate Device AutoSure Voice II Blood Glucose Monitoring System and AutoSure Blood Glucose Test Strips (k102037) Device Description The AutoSure Voice II Blood Glucose Monitoring System consists of the AutoSure Voice… | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K102037.
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. 2015, 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 AutoSure Voice Il Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is…
Read the full statement (280 words)
The AutoSure Voice Il Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is for single-patient use only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice Il Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice I Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
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/K150396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150396: Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150396
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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