510(k) · Cleared
ClearedEps Easy Pain Supreme 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. · CGA Glucose Oxidase, Glucose
Cleared on Apr 29, 2005 as substantially equivalent to K971812 (Medisense, Inc., 1997) after a 157-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 29, 2005
- Review
- 157 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945887 (1995). 8 ancestors in all, the oldest K896951 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 3 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 2 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 1 generation backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- This deviceK043245 Eps Easy Pain Supreme Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2005
- Descendant · cites it directly · 1 of its ownK061992 Easyplus Self Monitoring Glucose Test System, Model EPS04014Eps Bio Technology Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK081796 Easyplus Mini R2N Self Monitoring Glucose Test SystemEps Bio Technology Corp. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −3 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −2 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −1 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripSummary page 1…m 3.0 Classification: Class II 4.0 Predicate Device: The predicate device is the Precision ® QID Blood Glucose Testin. System (K 971812) marketed by Medisense Inc. 5.0 Device Description: The Easy Pain Supreme Self-Monitoring Blood Glucose System… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061992 | Easyplus Self Monitoring Glucose Test System, Model EPS04014 | 2006 | 1 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K061992 (Eps Bio Technology Corp., 2006) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K971812.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043245: Eps Easy Pain Supreme 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/K043245
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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