510(k) · Cleared
Recalled · Class II · 2023Contour® next GEN 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 Dec 23, 2021 as substantially equivalent to K160682 (Ascensia Diabetes Care, 2016) after a 745-day review. Its family tree reaches back 7 generations to 2003. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2021
- Review
- 745 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K030531 (2003). 10 ancestors in all. 5 later devices descend from it, 3 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 deviceK193407 Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
- Descendant · cites it directly · 2 of its ownK223293 CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241787 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT…Ascensia Diabetes Care U.S., Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT…Ascensia Diabetes Care · 2026
- Descendant · cites it directly · 0 of its ownK231679 CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2024
- Descendant · cites it directly · 0 of its ownK231476 TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood…Sinocare, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2022 · cites it directly2descendants
- K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc. · 2024 · 2 generations on1descendant
- K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care · 2026 · 3 generations on0descendants
- K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2024 · cites it directly0descendants
- K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc. · 2023 · 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) | K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | — |
| +1 | K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022 | — |
| +2 | K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood… | Ascensia Diabetes Care U.S., Inc. | 2024 | — |
| +3 | K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood… | Ascensia Diabetes Care | 2026 | — |
| +1 | K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2024 | — |
| +1 | K231476 | TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose… | Sinocare, Inc. | 2023 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring SystemSummary page 4…75 NBW; Glucose Test System, OTC 3) Predicate device: Contour® Next ONE Blood Glucose Monitoring System (K160682) 4) Device description: Contour® next GEN Blood Glucose Monitoring System is a blood glucose me… | 2016 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2023 | Class II | Z-2211-2023 | Process control | Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the… |
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 3.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K223293 (Ascensia Diabetes Care U.S., Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K160682.
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 GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next test strips and the Contour® Diabetes app. The Contour® next Gen Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The…
Read the full statement (145 words)
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next test strips and the Contour® Diabetes app.
The Contour® next Gen Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193407: Contour® next GEN 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/K193407
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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