510(k) · Cleared
ClearedCoaguChek XS Plus 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 Oct 24, 2025 as substantially equivalent to K180684 (Roche Diagnostics, 2018) after a 28-day review. Its family tree reaches back 5 generations to 2001. 2 of the 6 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 24, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010599 (2001). No later device cites it as a predicate yet. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 4 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 3 generations backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- 2 generations backK071041 Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Recalled (Class I)
- 1 generation backK180684 CoaguChek XS Plus SystemRoche Diagnostics · 2018 · Recalled (Class I)
- This deviceK253188 CoaguChek XS Plus SystemRoche Diagnostics · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −4 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −3 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| −2 | K071041 | Coaguchek XS Plus System | Roche Diagnostics | 2007 | Class I |
| −1 | K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018 | Class I |
| 0 (this device) | K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025 | — |
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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K180684 | CoaguChek XS Plus SystemSummary page 6…his Special 510(k) Premarket Notification is to obtain FDA review and clearance for the CoaguChek® XS Plus System for the following changes since its previous clearance, K180684: ● Meter housing: The meter housing material has remained the same as cleared under K180684, but now includes a c… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
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/K253188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253188: CoaguChek XS Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253188
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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