510(k) · Cleared
ClearedEasyplus Mini R2N Self Monitoring Glucose Test 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 Jan 23, 2009 as substantially equivalent to K061992 (Eps Bio Technology Corp., 2006) after a 212-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 23, 2009
- Review
- 212 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945887 (1995). 10 ancestors in all, the oldest K896951 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 2 generations backK043245 Eps Easy Pain Supreme Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2005
- 1 generation backK061992 Easyplus Self Monitoring Glucose Test System, Model EPS04014Eps Bio Technology Corp. · 2006
- This deviceK081796 Easyplus Mini R2N Self Monitoring Glucose Test SystemEps Bio Technology Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −4 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −3 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −2 | K043245 | Eps Easy Pain Supreme Self Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2005 | — |
| −1 | K061992 | Easyplus Self Monitoring Glucose Test System, Model EPS04014 | Eps Bio Technology Corp. | 2006 | — |
| 0 (this device) | K081796 | Easyplus Mini R2N Self Monitoring Glucose Test System | Eps Bio Technology Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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? (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 |
|---|---|---|---|
| * | K061992 | Easyplus Self Monitoring Glucose Test System, Model EPS04014Summary page 3…ate device name(s) EasyPlus Self-Monitoring Blood Glucose System 2 Device Company EPS Bio Technology Corporation 3 Predicate 510(k) number(s) k061992 4 Comparison with predicate Similarities Item Dev… | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a 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?
The EasyPlus mini R2N Self Monitoring Blood Glucose 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 (In Vitro 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 momtor the effectiveness of diabetes control The…
Read the full statement (272 words)
The EasyPlus mini R2N Self Monitoring Blood Glucose 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 (In Vitro 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 momtor the effectiveness of diabetes control
The EasyPlus min R2N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Meter Testing is done outside the body (In Vitro 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 morntor the effectiveness of diabetes control
The EasyPlus miraR2N 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 R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Blood Glucose Meter Testing is done outside the body (In Vitro 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 monmtor the effectiveness of diabetes control
For use with the EasyPlus mumn R2N meter and EasyPlus mini R2N 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 summary.
https://510kreport.com/device/K081796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081796: Easyplus Mini R2N Self Monitoring Glucose Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081796
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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