510(k) · Cleared
ClearediGlucose Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionime Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 2, 2017 as substantially equivalent to K143387 (Bionime Coporation, 2015) after a 307-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- May 2, 2017
- Review
- 307 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 6 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 5 generations backK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
- 4 generations backK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · Recalled
- 3 generations backK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
- 2 generations backK092052 Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
- 1 generation backK143387 GE333 Blood Glucose Monitoring SystemBionime Coporation · 2015
- This deviceK161790 iGlucose Blood Glucose Monitoring SystemBionime Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −5 | K042678 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2005 | 1 |
| −4 | K053635 | Modification to Rightest Blood Glucose Monitoring System | Bionime Corporation | 2006 | 1 |
| −3 | K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2007 | 1 |
| −2 | K092052 | Rightest Blood Glucose Monitoring System, Model GM550 | Bionime Corporation | 2010 | — |
| −1 | K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | 2015 | — |
| 0 (this device) | K161790 | iGlucose Blood Glucose Monitoring System | Bionime Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K143387 | GE333 Blood Glucose Monitoring SystemSummary page 4…GE Blood Glucose Monitoring System 333 (listed in FDA’s database as Ge333 Blood Glucose Monitoring System), k143387 6. Device Description and Principle of Operation: The iGlucose Blood Glucose Monitoring System consists of the iGlucose meter, th… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K143387.
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. 2017, 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 iGlucose Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The iGlucose Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid…
Read the full statement (133 words)
The iGlucose Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The iGlucose Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iGlucose Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The iGlucose Blood Glucose Test Strips are for use with the iGlucose Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161790: iGlucose 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/K161790
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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