510(k) · Cleared
ClearedEM40 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. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 15, 2014 after a 161-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Apr 15, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK133389 EM40 Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
- Descendant · cites it directly · 0 of its ownK190189 MDT2 BLE Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190189MDT2 BLE Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133389 | EM40 Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2014 | — |
| +1 | K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | 2019 | 0 |
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?
- Of its descendants, K190189 (Eps Bio Technology Corp., 2019) has gone furthest, with 0 descendants of its own.
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. 2014, 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 EM4O Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing isdone outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional hsealtlhcare 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 (316 words)
The EM4O Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing isdone outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional hsealtlhcare 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 lbr the diagnosis of. or screening for diabetes mellitus.
The system consists of the EM4O Pro meter and the EM40 Pro test strips. The EM4O Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EM4O Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EM4O Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose inl fresh capillary whole blood from fingertip, palm, 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 onl 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 EM4O meter and the EM4O test strips. The EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EM40 Glucose Control Solution is for use with EM40 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 summary.
https://510kreport.com/device/K133389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133389: EM40 Self-Monitoring Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133389
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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