510(k) · Cleared
ClearedRightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest New Adapters-3,GE Diabetes Managem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionime Coporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 17, 2014 as substantially equivalent to K110737 (Bionime Corporation, 2012) and 4 other predicates after a 153-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Apr 17, 2014
- Review
- 153 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K024194 (2003). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 6 generations backK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
- 5 generations backK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · Recalled
- 4 generations backK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
- 3 generations backK092052 Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
- 2 generations backK110737 Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012
- 1 generation backK123008 Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood…Bionime Corporation · 2013
- This deviceK133522 Rightest Diabetes Management Software and Adapter (Existing Cleared…Bionime Coporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −6 | K042678 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2005 | 1 |
| −5 | K053635 | Modification to Rightest Blood Glucose Monitoring System | Bionime Corporation | 2006 | 1 |
| −4 | K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2007 | 1 |
| −3 | K092052 | Rightest Blood Glucose Monitoring System, Model GM550 | Bionime Corporation | 2010 | — |
| −2 | K110737 | Rightest Blood Glucose Monitoring System GM700 | Bionime Corporation | 2012 | — |
| −1 | K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose… | Bionime Corporation | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 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? (5)
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 GM700 | 2012 |
| * | K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…Summary page 6…below. Name: Rightest Blood Glucose Monitoring System GM700 Device Company: Bionime Corporation 5 10O(K) Number: Ki 10737 and K1 23008 Name: Rightest Blood Glucose Monitoring System GM650 Device Company: Bionime Corporation 5… | 2013 |
| * | K120423 | Bionime Rightest Blood Glucose Monitoring System, Model GM650Summary page 6…i 10737 and K1 23008 Name: Rightest Blood Glucose Monitoring System GM650 Device Company: Bionime Corporation 5 10(K) Number: K120423 and K123008 Name: Rightest Blood Glucose Monitoring System GM300 Device Company: Bionime Corpora… | 2012 |
| * | K062567 | Rightest Blood Glucose Monitoring SystemSummary page 6…K120423 and K123008 Name: Rightest Blood Glucose Monitoring System GM300 Device Company: Bionime Corporation 5 10(K) Number: K062567 Name: GE200 Blood Glucose Monitoring System Device Company: Bionime Corporation 5 10O(K) Nu… | 2007 |
| * | K113007 | Bionime Diabetes Management System VI.0 | 2012 |
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 11 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 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. 2014, 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 GE 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 the following glucose meters: GEIOO0 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5SO), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) and GE200 Blood Glucose Monitoring System…
Read the full statement (1,037 words)
The GE 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 the following glucose meters: GEIOO0 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5SO), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) and GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GPSSO) or GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users profile and data.
The GE 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 health care professional.
The Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood fromi the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System 0M300. This device is not intended for testing neonate blood samples.
Special conditions for use statement(s): Rightest System provides plasma equivalent results.
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 Bionime Rightest Diabetes Management System is Mnover-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 the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM25O with Rightest PC Link Adaptor (GPSSO), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (0P550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP6SO), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.
The Bionime Rightest 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.
The GE200 Blood Glucose Monitoring System is intended to be used for the quatiutative 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.
Thre GE200 Blood Glucose Systemu is intended for self testing outside the body (in vitro diagnostic use) by peopfe with diabetes at home as an aid to mionitor the effectiveness of diabetes control. The GE3200 Blood Glucose Monitoring System should not bc 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 wvith thie GE200 Blood Glucose Mleter 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 08300 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 Blood Glucose Test Strip is for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forea~n or palm.
The Rightest Blood Glucose Monitoring System 0M650 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 GM65O 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 ame 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133522: Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest New Adapters-3,GE Diabetes Managem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133522
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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