510(k) · Cleared
Recalled · Class I · 2018CoaguChek Vantus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · GJS Test, Time, Prothrombin
Cleared on Dec 25, 2017 as substantially equivalent to K062925 (Roche Diagnostics Corp., 2007) after a 269-day review. Its family tree reaches back 4 generations to 2001. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Dec 25, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010599 (2001). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 3 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 2 generations backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- 1 generation backK062925 Coaguchek XS SystemRoche Diagnostics Corp. · 2007 · Recalled
- This deviceK170960 CoaguChek Vantus SystemRoche Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −3 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −2 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| −1 | K062925 | Coaguchek XS System | Roche Diagnostics Corp. | 2007 | 4 |
| 0 (this device) | K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017 | — |
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.
1 device in this family has a Class I recall. 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 GJS device
- #1 K243543 microINR Systemscore 13.4 · 6 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 |
|---|---|---|---|
| * | K062925 | Coaguchek XS SystemSummary page 4…Prothrombin Time Test Product Codes, Regulation Numbers GJS, 21 CFR 864.7750 Predicate Devices CoaguChek XS System, K062925 For the CoaguChek Vantus System, the establishment registration… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2018 | Class I | Z-0360-2019 | Nonconforming Material/Component | Abnormally high INR test results with the affected CoaguChek test strips |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GJS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GJS
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJS
1in 2022
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GJS
105in 2025
MAUDE reports naming product code GJS, 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 | 4 | 77 | 5 | 439 |
| 2008 | 1 | — | 3 | 420 |
| 2009 | 0 | — | 4 | 876 |
| 2010 | 4 | 168 | 2 | 2,177 |
| 2011 | 0 | — | 1 | 2,965 |
| 2012 | 1 | — | 1 | 2,198 |
| 2013 | 1 | — | 1 | 2,584 |
| 2014 | 1 | — | 4 (3) | 2,397 |
| 2015 | 0 | — | 0 | 1,260 |
| 2016 | 1 | — | 0 | 864 |
| 2017 | 1 | — | 5 | 532 |
| 2018 | 2 | — | 3 (2) | 1,958 |
| 2019 | 2 | — | 0 | 2,385 |
| 2020 | 1 | — | 2 | 1,390 |
| 2021 | 0 | — | 1 | 1,359 |
| 2022 | 3 | 399 | 1 | 1,210 |
| 2023 | 2 | — | 0 | 809 |
| 2024 | 1 | — | 0 | 177 |
| 2025 | 3 | 60 | 0 | 105 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick. The system is intended for properly selected and suitable trained users on the prescription of the treating doctor. Users should be stabilized on…
Read the full statement (110 words)
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick.
The system is intended for properly selected and suitable trained users on the prescription of the treating doctor.
Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient self-testing with the CoaguChek Vantus System.
The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170960: CoaguChek Vantus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170960
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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