510(k) · Cleared
ClearedEasymax T1 Self Monitoring Blood Glucose System, Model EPS10042
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eps Bio Technology Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 21, 2011 after a 306-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 21, 2011
- Review
- 306 days
- Class
- Class II
- Product code
- NBW
- 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 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?
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 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?
The EasyMax TI Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, 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…
Read the full statement (352 words)
The EasyMax TI Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, 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. Alternative site testing can be only used during steady-state blood glucose conditions..
The system consists of the EasyMax TI Pro Meter and the EasyMax TI Pro Blood Glucose Test Strips. The EasyMax Ti Pro Meter is only used with the EasyMax Ti Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
EasyMax TI Glucose Control Solutions
For use with the EasyMax Ti Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EasyMax TI Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips 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 EasyMax TI Meter and the EasyMax TI Blood Glucose Test Strips. The EasyMax Ti Meter is only used with the EasyMax Ti test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
EasyMax TI Glucose Control Solutions
For use with the EasyMax Ti Self Monitoring Blood Glucose 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/K102345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102345: Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102345
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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