510(k) · Cleared
ClearedEusure Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eumed Biotechnology Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 14, 2004 as substantially equivalent to K002621 (Apex BioTechnology Corp., 2001) after a 121-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jul 14, 2004
- Review
- 121 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002621 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002621 Glucosure Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2001 · Recalled
- This deviceK040678 Eusure Blood Glucose Monitoring SystemEumed Biotechnology Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK062892 EukareEumed Biotechnology Co., Ltd. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K062892EukareEumed Biotechnology Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002621 | Glucosure Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2001 | 1 |
| 0 (this device) | K040678 | Eusure Blood Glucose Monitoring System | Eumed Biotechnology Co., Ltd. | 2004 | — |
| +1 | K062892 | Eukare | Eumed Biotechnology Co., Ltd. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K002621 | Glucosure Blood Glucose Monitoring SystemSummary page 1…Predicate Device: Claim of Substantial Equivalence (SE) is made to Apex Biotechnology CoTp. -- glucosure blood glucose monitoring system (K002621I) * Device Description: Based on an electrochemical biosensor technology and the principle of capil… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062892 | Eukare | 2007 | 0 |
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.
- Of its descendants, K062892 (Eumed Biotechnology Co., Ltd., 2007) has gone furthest, with 0 descendants of its own.
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.
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 EUSURE Blood Glucose Monitoring System is designed to measure the blood
glucose levels in capillary whole blood. The system is suitable for diabetic
patients 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. The test range is from 30 mgldL to 600 mgldL ( 1.67 -
3.33 mmol/L).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040678: Eusure Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040678
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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