510(k) · Cleared
ClearedRightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin
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 Jan 25, 2013 as substantially equivalent to K110737 (Bionime Corporation, 2012) and 1 other predicate after a 120-day review. Its family tree reaches back 6 generations to 2003. 2 later devices descend from it.
- Decided
- Jan 25, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K024194 (2003). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK110737 Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012
- This deviceK123008 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 2 of 2 · See all- 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 |
|---|---|---|---|---|---|
| −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 | K110737 | Rightest Blood Glucose Monitoring System GM700 | Bionime Corporation | 2012 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K110737 | Rightest Blood Glucose Monitoring System GM700Summary page 4…System noted below. Name: Rightest Blood Glucose Monitoring System GM700 Device Company: Bionime Corporation 510(K) Number: K1 10737. The Rightest Blood Glucose Monitoring System GM650 and the GE300 Talking Blood Glucose Monitoring System are substa… | 2012 |
| * | K120423 | Bionime Rightest Blood Glucose Monitoring System, Model GM650Summary page 4…System noted below. Name: Rightest Blood Glucose Monitoring System GM650 Device Company: Bionime Corporation 510(K) Number: K1 20423. 7. Comparison to Predicate Devices: Specification Comparison New Device… | 2012 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K141292 (Bionime Coporation, 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K110737.
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. 2013, 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 GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by…
Read the full statement (650 words)
The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM700 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 GM700 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 Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE200 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, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GE200 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 GE200 Blood Glucose Monitoring System 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 GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.
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 Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE300 Talking 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, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GE300 Talking 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 GE300 Talking Blood Glucose Monitoring System 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 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123008: Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123008
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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