510(k) · Cleared
ClearedEasyplus Mini R13N 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 Aug 18, 2009 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 18, 2009
- Review
- 91 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. 2009, 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?
EasyPlus mini R13N SMBG Test System The EasyPlus mini R13N SMBG Test 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 (InVitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes…
Read the full statement (290 words)
EasyPlus mini R13N SMBG Test System
The EasyPlus mini R13N SMBG Test 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 (InVitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EasyPlus mini R13N Meter
The EasyPlus mini R13N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Meter. Testing is done outside the body (InVitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EasyPlus mini R13N Blood Glucose Test Strips
The EasyPlus mini Rl3N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Blood Glucose Meter. Testing is done outside the body (InVitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EasyPlus mini RI3N Glucose Control Solutions
For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips 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/K091481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091481: Easyplus Mini R13N 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/K091481
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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