510(k) · Cleared
ClearedBionime Rightest Blood Glucose Monitoring System, Model GM650
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 Aug 3, 2012 as substantially equivalent to K092052 (Bionime Corporation, 2010) after a 172-day review. Its family tree reaches back 5 generations to 2003. 3 later devices descend from it.
- Decided
- Aug 3, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K024194 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 4 generations backK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
- 3 generations backK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · Recalled
- 2 generations backK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
- 1 generation backK092052 Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
- This deviceK120423 Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 2012
- Descendant · cites it directly · 2 of its ownK123008 Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood…Bionime Corporation · 2013
- Descendant · cites it directly · 0 of its ownK141292 Rightest Blood Glucose Monitoring System GM700, Rightest Blood…Bionime Coporation · 2015
- Descendant · cites it directly · 0 of its ownK133522 Rightest Diabetes Management Software and Adapter (Existing Cleared…Bionime Coporation · 2014
Most influential descendants
Showing 3 of 3 · See all- K123008Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…Bionime Corporation · 2013 · cites it directly2descendants
- K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System…Bionime Coporation · 2015 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −4 | K042678 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2005 | 1 |
| −3 | K053635 | Modification to Rightest Blood Glucose Monitoring System | Bionime Corporation | 2006 | 1 |
| −2 | K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2007 | 1 |
| −1 | K092052 | Rightest Blood Glucose Monitoring System, Model GM550 | Bionime Corporation | 2010 | — |
| 0 (this device) | K120423 | Bionime Rightest Blood Glucose Monitoring System, Model GM650 | Bionime Corporation | 2012 | — |
| +1 | K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose… | Bionime Corporation | 2013 | — |
| +1 | K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose… | Bionime Coporation | 2015 | — |
| +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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K092052 | Rightest Blood Glucose Monitoring System, Model GM550Summary page 2…gement System is substantially equivalent to the predicate device noted below: Device Name: RighteStTM Blood Glucose Monitoring System, Model GM550 5 10k No.: k092052 Device Company: Bionime Corporation 13 Bionim… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System… | 2013 | 2 |
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System… | 2015 | 0 |
| 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K123008 (Bionime Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K092052.
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. 2012, 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 Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an…
Read the full statement (407 words)
The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only.
The Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The Rightest Control Solution Set GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS65O to check that the meters and test strip are working together properly and that the test is performing correctly.
The GE talking blood glucose monitoring system Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE talking blood glucose monitoring system Model GE300 is intended for single patient use only.
The GE talking blood glucose monitoring system Model GE300 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 GE talking blood glucose monitoring system Model GE300 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120423: Bionime Rightest Blood Glucose Monitoring System, Model GM650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120423
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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