510(k) · Cleared
ClearedCONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless 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 Nov 8, 2019 as substantially equivalent to K160430 (Ascensia Diabetes Care U.S., Inc., 2016) and 3 other predicates after a 179-day review. Its family tree reaches back 7 generations to 2003. 1 later device descends from it.
- Decided
- Nov 8, 2019
- Review
- 179 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K030531 (2003). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
- 6 generations backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- 5 generations backK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- 4 generations backK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- 3 generations backK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- 2 generations backK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
- 1 generation backK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
- This deviceK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- Descendant · cites it directly · 0 of its ownK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
Most influential descendants
Showing 1 of 1 · See all- K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | 3 |
| −6 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| −5 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| −4 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| −3 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| −2 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
| −1 | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016 | — |
| 0 (this device) | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Summary page 8…(21 C.F.R. Section 862.1234) 3) Predicate CONTOUR® NEXT ONE Blood Glucose Monitoring Systems: device: CONTOUR® NEXT (K160430) CONTOUR® NEXT USB (K150942) CONTOUR® NEXT ONE (K160682) CON… | 2016 |
| * | K150942 | Contour Next USB Blood Glucose Monitoring SystemSummary page 8…Predicate CONTOUR® NEXT ONE Blood Glucose Monitoring Systems: device: CONTOUR® NEXT (K160430) CONTOUR® NEXT USB (K150942) CONTOUR® NEXT ONE (K160682) CONTOUR® NEXT EZ (K162336) CONT… | 2015 |
| * | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring SystemSummary page 8…Monitoring Systems: device: CONTOUR® NEXT (K160430) CONTOUR® NEXT USB (K150942) CONTOUR® NEXT ONE (K160682) CONTOUR® NEXT EZ (K162336) CONTOUR® NEXT LINK Wireless (K160430) 4) Device… | 2016 |
| * | K162336 | Contour Next EZ Blood Glucose Monitoring SystemSummary page 8…CONTOUR® NEXT (K160430) CONTOUR® NEXT USB (K150942) CONTOUR® NEXT ONE (K160682) CONTOUR® NEXT EZ (K162336) CONTOUR® NEXT LINK Wireless (K160430) 4) Device The CONTOUR® NEXT Blood Glucose Test Strips… | 2017 |
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 |
|---|---|---|---|
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | 2021 | 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 16 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K210687 (Ascensia Diabetes Care, 2021) 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. 2019, 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 system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ Blood…
Read the full statement (879 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 system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ Blood Glucose Monitoring System is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EX EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The CONTOUR® NEXT Blood Glucose Monitoring System is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a CONTOUR® NEXT blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions. CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT Blood Glucose Monitoring System is not intended for the diagnosis or screening for diabetes mellitus and its not intended for use on neonates.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
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 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 draw from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared.
The system consists of a CONTOUR® NEXT USB blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions.
The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The CONTOUR® NEXT USB Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191286: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless 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/K191286
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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