510(k) · Cleared
ClearedContour Next Link Wireless Blood Glucose Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare · LFR Glucose Dehydrogenase, Glucose
Cleared on Mar 28, 2012 as substantially equivalent to K091820 (Bayer Healthcare, 2009) and 2 other predicates after a 364-day review. Its family tree reaches back 3 generations to 2003. 13 later devices descend from it.
- Decided
- Mar 28, 2012
- Review
- 364 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K030531 (2003). 6 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
- 2 generations backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- 1 generation backK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- This deviceK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- Descendant · cites it directly · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- Descendant · 2 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
- Descendant · 3 generations on · 8 of its ownK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
- Descendant · 4 generations on · 5 of its ownK193407 Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · Recalled
- Descendant · cites it directly · 3 of its ownK122370 Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · cites it directly10descendants
- K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 2 generations on9descendants
- K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016 · 3 generations on8descendants
- K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 4 generations on5descendants
- K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | 3 |
| −2 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| −1 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| 0 (this device) | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| +1 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| +2 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
| +3 | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016 | — |
| +4 | K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | 1 |
| +1 | K122370 | Contour Next Link Wireless Blood Glucose Monitor | Bayer Healthcare | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes…Summary page 1…e Dehyrogenase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter) Legally marketed Predicate 1 Contour UISB (K091820), Predicate 2 One Touch Ultralink device(s) to which (K073231), Predicate 3 Care Link USB (K070438) equivalence is… | 2009 |
| * | K073231 | Onetouch Ultralink Blood Glucose Monitoring SystemSummary page 1…Over The Counter) Legally marketed Predicate 1 Contour UISB (K091820), Predicate 2 One Touch Ultralink device(s) to which (K073231), Predicate 3 Care Link USB (K070438) equivalence is claimed Reason for 510(k) This submission reports a modificat… | 2008 |
| * | K070438 | Medtronic Minimed Carelink Usb Connector, Model NMT 7305Summary page 1…gally marketed Predicate 1 Contour UISB (K091820), Predicate 2 One Touch Ultralink device(s) to which (K073231), Predicate 3 Care Link USB (K070438) equivalence is claimed Reason for 510(k) This submission reports a modification of the Contour UISB meter (K09182… | 2007 |
What descends from it? (13)
See all 132 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 9 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K121087 (Bayer Healthcare, 2012) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K091820.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 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. The system consists of a Contour…
Read the full statement (230 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. The system consists of a Contour NEXT LINK Wireless 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 from 20 to 600 mg/dL.
The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.
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 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/K110894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110894: Contour Next Link Wireless 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/K110894
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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