510(k) · Cleared
ClearedRightest Blood Glucose Monitoring System, Model GM550
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 Jun 18, 2010 as substantially equivalent to K042678 (Bionime Corporation, 2005) and 2 other predicates after a 346-day review. Its family tree reaches back 4 generations to 2003. 10 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 346 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K024194 (2003). 10 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 3 generations backK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
- 2 generations backK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · Recalled
- 1 generation backK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
- This deviceK092052 Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
- Descendant · cites it directly · 4 of its ownK110737 Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012
- Descendant · cites it directly · 3 of its ownK143387 GE333 Blood Glucose Monitoring SystemBionime Coporation · 2015
- Descendant · cites it directly · 3 of its ownK120423 Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 2012
- Descendant · 2 generations on · 2 of its ownK123008 Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood…Bionime Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK170143 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring…Bionime Corporation · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110737Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012 · cites it directly4descendants
- K143387GE333 Blood Glucose Monitoring SystemBionime Coporation · 2015 · cites it directly3descendants
- K120423Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 2012 · cites it directly3descendants
- K123008Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…Bionime Corporation · 2013 · 2 generations on2descendants
- K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…Bionime Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −3 | K042678 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2005 | 1 |
| −2 | K053635 | Modification to Rightest Blood Glucose Monitoring System | Bionime Corporation | 2006 | 1 |
| −1 | K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2007 | 1 |
| 0 (this device) | K092052 | Rightest Blood Glucose Monitoring System, Model GM550 | Bionime Corporation | 2010 | — |
| +1 | K110737 | Rightest Blood Glucose Monitoring System GM700 | Bionime Corporation | 2012 | — |
| +1 | K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | 2015 | — |
| +1 | K120423 | Bionime Rightest Blood Glucose Monitoring System, Model GM650 | Bionime Corporation | 2012 | — |
| +2 | K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose… | Bionime Corporation | 2013 | — |
| +2 | K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System… | Bionime Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K042678 | Rightest Blood Glucose Monitoring SystemSummary page 2…Name: Rightest Blood Glucose Monitoring System Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Specification Comparison… | 2005 |
| * | K053635 | Modification to Rightest Blood Glucose Monitoring SystemSummary page 2…Name: Rightest Blood Glucose Monitoring System Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Specification Comparison… | 2006 |
| * | K062567 | Rightest Blood Glucose Monitoring SystemSummary page 2…: Rightest Blood Glucose Monitoring System Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Specification Comparison _________… | 2007 |
What descends from it? (10)
3 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 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K110737 (Bionime Corporation, 2012) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K042678.
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. 2010, 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, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes…
Read the full statement (144 words)
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.
This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.
Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.
Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092052: Rightest Blood Glucose Monitoring System, Model GM550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092052
Report an extraction error
Are you the manufacturer?
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