510(k) · Cleared
ClearedEG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eps Bio Technology Corp. · LFR Glucose Dehydrogenase, Glucose
Cleared on May 23, 2011 as substantially equivalent to K062058 (Bayer Healthcare, 2006) after a 404-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- May 23, 2011
- Review
- 404 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062058 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- This deviceK101037 EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017Eps Bio Technology Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| 0 (this device) | K101037 | EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017 | Eps Bio Technology Corp. | 2011 | — |
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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Summary page 2…ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7050 2. Device Company BAYER HEALTHCARE 3. Predicate 510(k) number(s): k062058 4.Cmparison with predicate: ____________________Similarities Item… | 2006 |
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 a recall.
- 6 other devices also cite its predicate K062058.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to mbnitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to…
Read the full statement (342 words)
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to mbnitor 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 EG V1 Pro meter and the EG Pro Test Strips. The EG V1 Pro meter only is used with the EG Pro Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip.
EG Glucose Control Solution
For use with the EG Vi Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantiatative measurement of glucose in fresh capillary whole blood from the 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 on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.
The system consists of the EG V1 (BL) meter and the EG V1 Test Strips. The EG V1 (BL) meter only is used with the EG V1 Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip, palm, or forearm.
EG Glucose Control Solution
For use with the EG Vi Pro 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/K101037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101037: EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101037
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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