510(k) · Cleared
ClearedEbsensor Blood Glucose Monitoring System, Model EB-G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visgeneer, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Dec 27, 2006 as substantially equivalent to K043197 (Lifescan, Inc., 2005) after a 119-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Dec 27, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043197 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043197 Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2005 · Recalled
- This deviceK062555 Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK122181 Ebchek Blood Glucose Monitoring SystemVisgeneer, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK091765 Ebcarryon Blood Glucose Monitoring SystemVisgeneer, Inc. · 2010
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 |
|---|---|---|---|---|---|
| −1 | K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2005 | 3 |
| 0 (this device) | K062555 | Ebsensor Blood Glucose Monitoring System, Model EB-G | Visgeneer, Inc. | 2006 | — |
| +1 | K122181 | Ebchek Blood Glucose Monitoring System | Visgeneer, Inc. | 2013 | — |
| +1 | K091765 | Ebcarryon Blood Glucose Monitoring System | Visgeneer, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemSummary page 1…* Predicate Device: Claim of Substantial Equivalence (SE) is made to LIFESCAN, INC. - One Touch Ultra Blood Glucose Monitoring System (K043197) * Device Description: Based on an electrochemical biosensor technology and the principle of… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062555: Ebsensor Blood Glucose Monitoring System, Model EB-G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062555
Report an extraction error
Are you the manufacturer?
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