510(k) · Cleared
Recalled · Class I · 2018Coaguchek XS Pro 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 Mar 18, 2010 as substantially equivalent to K071041 (Roche Diagnostics, 2007) after a 132-day review. Its family tree reaches back 4 generations to 2001. 2 of the 6 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Mar 18, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010599 (2001). 1 later device descends from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have 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 backK071041 Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Recalled (Class I)
- This deviceK093460 Coaguchek XS Pro SystemRoche Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK180693 CoaguChek XS Pro SystemRoche Diagnostics · 2018
Class I recalls in this family
- K071041 Coaguchek XS Plus Systemdirect predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K180693CoaguChek XS Pro SystemRoche Diagnostics · 2018 · cites it directly0descendants
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 | K071041 | Coaguchek XS Plus System | Roche Diagnostics | 2007 | Class I |
| 0 (this device) | K093460 | Coaguchek XS Pro System | Roche Diagnostics | 2010 | — |
| +1 | K180693 | CoaguChek XS Pro System | Roche Diagnostics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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 |
|---|---|---|---|
| * | K071041 | Coaguchek XS Plus SystemSummary page 1…tended for similar use. Most notably, the CoaguChek XS Pro System is a modification of the previously cleared CoaguChek XS Plus System (K071041). 4) Device The CoaguChek XS Pro System represents a modification of the CoaguChek Description XS Plus System to in… | 2007 |
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 |
|---|---|---|---|
| K180693 | CoaguChek XS Pro System | 2018 | 0 |
Has anything in its family been recalled? (2 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 |
| May 16, 2013 | Class II | Z-1582-2013 | 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. |
| Mar 6, 2013 | Class II | Z-1114-2013 | Device Design | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size… |
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.
- K071041Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180693 (Roche Diagnostics, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071041.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Pro System (CoaguChiek XS Pro meter and CoguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093460: Coaguchek XS Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093460
Report an extraction error
Are you the manufacturer?
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