510(k) · Cleared
Recalled · Class II · 2016Trueresult Blood Glucose System E4H01-81
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 19, 2008 after a 166-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 19, 2008
- Review
- 166 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK080641 Trueresult Blood Glucose System E4H01-81Home Diagnostics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova Biomedical Corporation · 2013
- Descendant · cites it directly · 0 of its ownK112352 Glucose Meter-Check Control for Nipro TrueresultBionostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK091460 Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086…American Biological Technologies, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K122435Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012 · cites it directly1descendant
- K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation · 2013 · 2 generations on0descendants
- K112352Glucose Meter-Check Control for Nipro TrueresultBionostics, Inc. · 2011 · cites it directly0descendants
- K091460Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087American Biological Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080641 | Trueresult Blood Glucose System E4H01-81 | Home Diagnostics, Inc. | 2008 | — |
| +1 | K122435 | Nova One Blood Glucose Monitor | Nova Biomedical Corporation | 2012 | — |
| +2 | K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System | Nova Biomedical Corporation | 2013 | — |
| +1 | K112352 | Glucose Meter-Check Control for Nipro Trueresult | Bionostics, Inc. | 2011 | — |
| +1 | K091460 | Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087 | American Biological Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2016 | Class II | Z-2880-2016 | Nonconforming Material/Component | Product gives incorrect low blood glucose levels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122435 (Nova Biomedical Corporation, 2012) has gone furthest, with 1 descendant 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. 2008, 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 TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.
Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.
Not for neonatal use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080641 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080641: Trueresult Blood Glucose System E4H01-81.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080641
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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