510(k) · Cleared
ClearedRightest Blood Glucose Monitoring System, Model GM100
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 Sep 18, 2008 as substantially equivalent to K042678 (Bionime Corporation, 2005) and 2 other predicates after a 118-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Sep 18, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K024194 (2003). 2 later devices descend from it, 1 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 deviceK081451 Rightest Blood Glucose Monitoring System, Model GM100Bionime Corporation · 2008
- Descendant · cites it directly · 1 of its ownK102751 Labonacheck Gluppy Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK140141 Labonacheck Gluppy Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K081451 | Rightest Blood Glucose Monitoring System, Model GM100 | Bionime Corporation | 2008 | — |
| +1 | K102751 | Labonacheck Gluppy Blood Glucose Monitoring System | Ceragem Medisys, Inc. | 2013 | — |
| +2 | K140141 | Labonacheck Gluppy Blood Glucose Monitoring System | Ceragem Medisys, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 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…Site Testing) noted below. Name: Rightest Blood Glucose Monitoring System, model GM100 Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Similarities Item… | 2005 |
| * | K053635 | Modification to Rightest Blood Glucose Monitoring SystemSummary page 2…esting) noted below. Name: Rightest Blood Glucose Monitoring System, model GM100 Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Similarities Item… | 2006 |
| * | K062567 | Rightest Blood Glucose Monitoring SystemSummary page 2…d below. Name: Rightest Blood Glucose Monitoring System, model GM100 Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567 7. Comparison to Predicate Devices: Similarities Item Subject… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102751 | Labonacheck Gluppy Blood Glucose Monitoring System | 2013 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K102751 (Ceragem Medisys, Inc., 2013) has gone furthest, with 1 descendant 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. 2008, 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 is intended for in vitro diagnostic use
(outside of body). It is indicated to be used by professional healthcare personnel or
diabetics at home to measure the glucose concentration for aiding diabetes management.
The glucose concentration is measured with quantitative capillary whole blood from the
fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System. This
device is not intended for testing neonate blood samples.
Special conditions for use statement(s): Rightest System provides plasma equivalent
results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081451: Rightest Blood Glucose Monitoring System, Model GM100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081451
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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