510(k) · Cleared
ClearedContour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascensia Diabetes Care U.S., Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 24, 2016 as substantially equivalent to K122370 (Bayer Healthcare, 2013) and 1 other predicate after a 129-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- Jun 24, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K030531 (2003). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
- 4 generations backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- 3 generations backK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- 2 generations backK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- 1 generation backK122370 Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare · 2013
- This deviceK160430 Contour Next Link Wireless Blood Glucose Monitoring System, Contour…Ascensia Diabetes Care U.S., Inc. · 2016
- Descendant · cites it directly · 1 of its ownK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- Descendant · 2 generations on · 0 of its ownK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | 3 |
| −4 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| −3 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| −2 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| −1 | K122370 | Contour Next Link Wireless Blood Glucose Monitor | Bayer Healthcare | 2013 | — |
| 0 (this device) | K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood… | Ascensia Diabetes Care U.S., Inc. | 2016 | — |
| +1 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| +2 | 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 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K122370 | Contour Next Link Wireless Blood Glucose MonitorSummary page 5…ext Link Wireless Blood Glucose Monitoring devices: System: Contour Next Link Wireless Blood Glucose Monitoring System K122370 Contour Next Blood Glucose Monitoring System: Contour Next Blood Glucose Monitoring Syst… | 2013 |
| * | K121190 | Contour Next Blood Glucose MeterSummary page 5…ng System K122370 Contour Next Blood Glucose Monitoring System: Contour Next Blood Glucose Monitoring System K121190 Page 1 of 11 4) Device Conto… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | 2019 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K191286 (Ascensia Diabetes Care, 2019) has gone furthest, with 1 descendant 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. 2016, 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 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…
Read the full statement (399 words)
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 is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160430: Contour Next Link Wireless Blood Glucose Monitoring System, Contour 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/K160430
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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