510(k) · Cleared
ClearedContour Next EZ Blood Glucose Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 23, 2014 as substantially equivalent to K111268 (Bayer Healthcare, 2012) after a 504-day review. Its family tree reaches back 2 generations to 2006. 5 later devices descend from it.
- Decided
- Jun 23, 2014
- Review
- 504 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062058 (2006). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- 1 generation backK111268 Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare · 2012 · Recalled
- This deviceK130265 Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
- Descendant · cites it directly · 2 of its ownK162336 Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- Descendant · cites it directly · 1 of its ownK162203 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
- Descendant · 2 generations on · 0 of its ownK181316 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017 · cites it directly2descendants
- K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care · 2019 · 2 generations on1descendant
- K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017 · cites it directly1descendant
- K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 3 generations on0descendants
- K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| −1 | K111268 | Contour (R) Next Blood Glucose Monitoring System | Bayer Healthcare | 2012 | 1 |
| 0 (this device) | K130265 | Contour Next EZ Blood Glucose Meter | Bayer Healthcare, LLC | 2014 | — |
| +1 | K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2017 | — |
| +2 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| +1 | K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2017 | — |
| +3 | K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | — |
| +2 | K181316 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K111268 | Contour (R) Next Blood Glucose Monitoring SystemSummary page 1…ate Contour Next EZ Blood Glucose Meter (Reference: device: Contour Next EZ Blood Glucose Monitoring System (K1 11268)) 4) Device The Contour Next EZ Blood Glucose Meter consists of a description: small handheld blood glu… | 2012 |
What descends from it? (5)
2 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 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K162336 (Ascensia Diabetes Care U.S., Inc., 2017) has gone furthest, with 2 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. 2014, 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 Contour Next 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 (138 words)
The Contour Next 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130265: Contour Next EZ Blood Glucose Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130265
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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