510(k) · Cleared
ClearedCONTOUR® NEXT ONE Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascensia Diabetes Care · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 11, 2021 as substantially equivalent to K191286 (Ascensia Diabetes Care, 2019) after a 156-day review. Its family tree reaches back 8 generations to 2003.
- Decided
- Aug 11, 2021
- Review
- 156 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K030531 (2003). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
- 7 generations backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- 6 generations backK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- 5 generations backK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- 4 generations backK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- 3 generations backK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
- 2 generations backK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
- 1 generation backK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- This deviceK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | 3 |
| −7 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| −6 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| −5 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| −4 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| −3 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
| −2 | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016 | — |
| −1 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| 0 (this device) | K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Summary page 4…Classification name: NBW; Glucose Test System, OTC (21 C.F.R. Section 862.1345) 3) Predicate CONTOUR® NEXT ONE (K191286) Device: 4) Device CONTOUR® NEXT ONE Blood Glucose Monitoring System Description: is… | 2019 |
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 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 18 ancestors have a recall of any class.
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. 2021, 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 ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes…
Read the full statement (172 words)
The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The Contour® NEXT ONE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210687: CONTOUR® NEXT ONE Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210687
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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