510(k) · Cleared
ClearedEMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eps Bio Technology Corp. · CGA Glucose Oxidase, Glucose
Cleared on Sep 16, 2011 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 16, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended far multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor…
Read the full statement (311 words)
The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended far multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.
The EMV3 Glucose Control Solution
For use with the EMV3 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EMV3 meter and the EMV3 test strips. The EMVS meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.
The EMV3 Glucose Control Solution
For use with EMV3 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of,blood glucose test results.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111728: EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111728
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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