510(k) · Cleared
ClearedGlucose Meter-Check Solution for Bayer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 25, 2013 as substantially equivalent to K082395 (Bionostics, Inc., 2008) after a 30-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jan 25, 2013
- Review
- 30 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945887 (1995). 25 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations between
- 3 generations backK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 2 generations backK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- 1 generation backK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- This deviceK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 8 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 7 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 6 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 5 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 4 generations backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- 3 generations backK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 2 generations backK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- 1 generation backK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- This deviceK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −8 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −7 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −6 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −5 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −4 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| −3 | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| −2 | K070506 | SMS Multi Glucose Control, Model 2120049 | Medical Specialties Supply Co., Inc. | 2007 | — |
| −1 | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| 0 (this device) | K123966 | Glucose Meter-Check Solution for Bayer | Bionostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Summary page 1…Glucose'Meter'Check Solution for~ayer Candidate Device Item !K082395 Intended Glucose Meter-CheckO Solution is Same, with the addition of Bayer… | 2008 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 25 ancestors has a recall of any class.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Glucose Meter-Check Solution Bayer is intended to assess the performance of the following Bayer blood glucose test systems:
Bayer Contour Next blood glucose monitoring systems
*Bayer Breeze 2 blood glucose monitoring systems
*Bayer Contour and Contour TS blood glucose monitoring systems
Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123966: Glucose Meter-Check Solution for Bayer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123966
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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