510(k) · Cleared
ClearedContour Next Link Wireless Blood Glucose Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Sep 26, 2013 as substantially equivalent to K110894 (Bayer Healthcare, 2012) after a 416-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Sep 26, 2013
- Review
- 416 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K030531 (2003). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
- 3 generations backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- 2 generations backK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- 1 generation backK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- This deviceK122370 Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare · 2013
- Descendant · cites it directly · 2 of its ownK160430 Contour Next Link Wireless Blood Glucose Monitoring System, Contour…Ascensia Diabetes Care U.S., Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB…Ascensia Diabetes Care · 2019
- Descendant · 3 generations on · 0 of its ownK210687 CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
Most influential descendants
Showing 3 of 3 · See all- K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Ascensia Diabetes Care U.S., Inc. · 2016 · cites it directly2descendants
- K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care · 2019 · 2 generations on1descendant
- K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | 3 |
| −3 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| −2 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| −1 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| 0 (this device) | K122370 | Contour Next Link Wireless Blood Glucose Monitor | Bayer Healthcare | 2013 | — |
| +1 | K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood… | Ascensia Diabetes Care U.S., Inc. | 2016 | — |
| +2 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose… | Ascensia Diabetes Care | 2019 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K110894 | Contour Next Link Wireless Blood Glucose MeterSummary page 1…862.1345 Product code(s) LFR (Glucose Dehyrogenase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter) Legally marketed K1 10894 Contour* NEXT LINK Wireless Blood Glucose Meter device(s) to which equivalence is claimed ______________________… | 2012 |
| † | P120010 | Minimed 530G System | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose… | 2016 | 2 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K160430 (Ascensia Diabetes Care U.S., Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K110894.
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. 2013, 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 LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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. Contour NEXT Test Strips are…
Read the full statement (192 words)
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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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.
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 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 Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor 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/K122370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122370: Contour Next Link Wireless Blood Glucose Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122370
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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