510(k) · Cleared
Recalled · 2007Eukare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eumed Biotechnology Co., Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Jan 22, 2007 as substantially equivalent to K040678 (Eumed Biotechnology Co., Ltd., 2004) after a 118-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- Jan 22, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002621 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K040678 | Eusure Blood Glucose Monitoring SystemSummary page 1…* Predicate Device: Claim of Substantial Equivalence (SE) is made to EUMED Biotechnology Co., Ltd. EUSURE® glucosure blood glucose monitoring system (K040678) * Device Description: Based on an electrochemical biosensor technology and the principle of capillary… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2007 | Not classified | Z-0134-2008 | Software design | Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. CAUTION. The measurement of glucose in whole blood can be taken from…
Read the full statement (250 words)
The EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
CAUTION. The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.
The EUKARE Blood Glucose Test Strips are intended to measure the glucose levels in whole blood with the EUKARE® / EUSURE® Blood Glucose Monitoring System. It is suitable for persons with diabetes to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients.
CAUTION: The EUKARE Blood Glucose Test Stripsfor use with EUKARE®/ EUSURE®Blood Glucose MonitoringSystem only.
The EUKARE Blood Glucose Control Solution level I, level II, and level III are used as quality control material to verify the accuracy of the EUKARE® EUSURE® Blood Glucose Monitoring System. If you are not sure about the strip quality or the previous storage condition, you are recommended to perform a quality control check. The control test results should always fall within the designed range listed on the box in use.
CAUTION: The EUKCARE Blood Glucose ControlSolution for use with EUKARE® /EUSURE® Blood Glucose MonitoringSystem only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062892: Eukare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062892
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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