510(k) · Cleared
ClearedRIGHTEST Blood Glucose Monitoring System Max Tel
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 19, 2024 as substantially equivalent to K173638 (Bionime Corporation, 2018) after a 267-day review. Its family tree reaches back 3 generations to 2007. 1 later device descends from it.
- Decided
- Jan 19, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070585 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
- 2 generations backK140210 Rightest Blood Glucose Monitoring System ( GM720, Rightest…Bionime Corporation · 2014
- 1 generation backK173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation · 2018
- This deviceK231192 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
- Descendant · cites it directly · 0 of its ownK240637 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070585 | Accu-Chek Performa System | Roche Diagnostics Corp. | 2007 | 2 |
| −2 | K140210 | Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS… | Bionime Corporation | 2014 | — |
| −1 | K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose… | Bionime Corporation | 2018 | — |
| 0 (this device) | K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024 | — |
| +1 | K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…Summary page 4…se Test Strip, Control Solution, Lancing Device and Sterile Lancets. The RIGHTEST Blood Glucose Test Strip Max is the same as Test Strip Max cleared in K173638.The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | 2024 | 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 17 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K240637 (Bionime Corporation, 2024) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
RIGHTEST Blood Glucose Monitoring System Max Tel 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. It is intended to be used by a single person and should not be shared. RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the…
Read the full statement (139 words)
RIGHTEST Blood Glucose Monitoring System Max Tel 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. It is intended to be used by a single person and should not be shared.
RIGHTEST Blood Glucose Monitoring System Max Tel 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. It 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 Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231192: RIGHTEST Blood Glucose Monitoring System Max Tel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231192
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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