510(k) · Cleared
Recalled · Class II · 2015Contour (R) Next Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare · LFR Glucose Dehydrogenase, Glucose
Cleared on Mar 6, 2012 as substantially equivalent to K062058 (Bayer Healthcare, 2006) after a 307-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2012
- Review
- 307 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062058 (2006). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- This deviceK111268 Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare · 2012
- Descendant · cites it directly · 5 of its ownK130265 Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK162336 Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- Descendant · 2 generations on · 1 of its ownK162203 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014 · cites it directly5descendants
- K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017 · 2 generations on2descendants
- K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care · 2019 · 3 generations on1descendant
- K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017 · 2 generations on1descendant
- K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| 0 (this device) | K111268 | Contour (R) Next Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| +1 | K130265 | Contour Next EZ Blood Glucose Meter | Bayer Healthcare, LLC | 2014 | — |
| +2 | K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2017 | — |
| +3 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| +2 | K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2017 | — |
| +4 | K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 LFR? 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 |
|---|---|---|---|
| * | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Summary page 1…enase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter) Legally marketed Contour Blood Glucose Monitoring System (K062058) device(s) to which equivalence is claimed Reason for 510(k) Modified test strips and measurement algorithm submissio… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130265 | Contour Next EZ Blood Glucose Meter | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2015 | Class II | Z-2482-2015 | Device Design | If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CONTOURONEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared. The CONTOUR NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the…
Read the full statement (159 words)
The CONTOURONEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared. The CONTOUR NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
'The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
The CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111268: Contour (R) Next Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111268
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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