510(k) · Cleared
ClearedBionime Diabetes Management System VI.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionime Corporation · JQP Calculator/Data Processing Module, For Clinical Use
Cleared on Feb 27, 2012 as substantially equivalent to K091820 (Bayer Healthcare, 2009) after a 143-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Feb 27, 2012
- Review
- 143 days
- Class
- Class I
- Product code
- JQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091820 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK091820 Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts…Bayer Healthcare · 2009
- This deviceK113007 Bionime Diabetes Management System VI.0Bionime Corporation · 2012
- Descendant · cites it directly · 0 of its ownK133522 Rightest Diabetes Management Software and Adapter (Existing Cleared…Bionime Coporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K133522Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest…Bionime Coporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux… | Bayer Healthcare | 2009 | — |
| 0 (this device) | K113007 | Bionime Diabetes Management System VI.0 | Bionime Corporation | 2012 | — |
| +1 | K133522 | Rightest Diabetes Management Software and Adapter (Existing Cleared… | Bionime Coporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 JQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes…Summary page 2…etes Management System is substantially equivalent to the predicate device noted below: Device Name: Glucofacts® Deluxe Diabetes Management Software 5l1Ok No.: k091820 Device Company: Bayer Healthcare, LLC Technology Characteristics: The Bionime Diabetes Management System (GP200 Diabetes A… | 2009 |
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 |
|---|---|---|---|
| K133522 | Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest… | 2014 | 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?
How does its category compare?
All JQP devicesJQP Calculator/Data Processing Module, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JQP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JQP
Too few JQP 510(k)s in any year since 2007 to give a median.
Recalls per year · JQP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQP
113in 2025
MAUDE reports naming product code JQP, 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 | 0 | — | 3 | 22 |
| 2008 | 0 | — | 6 | 9 |
| 2009 | 0 | — | 9 | 14 |
| 2010 | 0 | — | 7 | 45 |
| 2011 | 0 | — | 9 | 128 |
| 2012 | 1 | — | 6 | 102 |
| 2013 | 0 | — | 5 | 46 |
| 2014 | 0 | — | 3 | 85 |
| 2015 | 0 | — | 10 | 142 |
| 2016 | 0 | — | 12 | 204 |
| 2017 | 0 | — | 2 | 110 |
| 2018 | 0 | — | 10 | 218 |
| 2019 | 0 | — | 2 | 253 |
| 2020 | 0 | — | 2 | 52 |
| 2021 | 0 | — | 0 | 105 |
| 2022 | 0 | — | 3 | 166 |
| 2023 | 0 | — | 0 | 171 |
| 2024 | 0 | — | 5 | 102 |
| 2025 | 0 | — | 1 | 113 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightesto Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the glucose readings, as well as to backup and to recover users' profile and data.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113007: Bionime Diabetes Management System VI.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113007
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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