510(k) · Cleared
Recalled · Class II · 2020Coaguchek XS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · GJS Test, Time, Prothrombin
Cleared on Jan 29, 2007 as substantially equivalent to K060978 (Roche Diagnostics, 2006) after a 123-day review. Its family tree reaches back 3 generations to 2001. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jan 29, 2007
- Review
- 123 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010599 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 2 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 1 generation backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- This deviceK062925 Coaguchek XS SystemRoche Diagnostics Corp. · 2007
- Descendant · cites it directly · 0 of its ownK170960 CoaguChek Vantus SystemRoche Diagnostics · 2017 · Recalled (Class I)
Class I recalls in this family
- K170960 CoaguChek Vantus Systemcites it directly · 2017
Most influential descendants
Showing 1 of 1 · See all- K170960CoaguChek Vantus SystemRoche Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −2 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −1 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| 0 (this device) | K062925 | Coaguchek XS System | Roche Diagnostics Corp. | 2007 | — |
| +1 | K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 1 |
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 |
|---|---|---|---|
| * | K060978 | Coaguchek XS SystemSummary page 1…Device The CoaguChek XS is a 3" generation Roche Diagnostic's CoaguChek meter Description which was cleared for professional use under premarket notification K060978. This premarket notification is being submitted to obtain clearance for patient self-testing.… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170960 | CoaguChek Vantus System Class I | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2020 | Class II | Z-0804-2021 | Device Design | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| May 16, 2013 | Class II | Z-1581-2013 | Software design | Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. |
| Jul 22, 2009 | Not classified | Z-2003-2009 | Device Design | The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports. |
| May 13, 2009 | Not classified | Z-1594-2009 | Other | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K170960CoaguChek Vantus SystemRoche Diagnostics · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K170960 (Roche Diagnostics, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K060978.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System uses blood from a finger stick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062925: Coaguchek XS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062925
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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