510(k) · Cleared
ClearedAutosure Voice 3 Blood Glucose Monitoring System and Test Strip
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 Apr 28, 2011 after a 241-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 28, 2011
- Review
- 241 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (2)
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 |
|---|---|---|---|
| * | — | AutoSure Voice II meter Named without a submission number | |
| * | — | AutoSure test strips Named without a submission number |
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.
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?
AutoSure Voice 3 Blood Glucose Monitoring System: The AutoSure Voice 3 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. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for lay use by people with diabetes as an aid to monitoring…
Read the full statement (193 words)
AutoSure Voice 3 Blood Glucose Monitoring System:
The AutoSure Voice 3 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. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Blood Glucose Test Strips:
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice 1I and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice 11 and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102481: Autosure Voice 3 Blood Glucose Monitoring System and Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026