510(k) · Cleared
Recalled · 2007Coaguchek System, Coaguchek System for Prothrombin Time Self Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Jan 9, 1998 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 5 times.
- Decided
- Jan 9, 1998
- Review
- 32 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 5
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPA? 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 JPA device
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2007 | Not classified | Z-0737-2007 | Other | The product was erroneously distributed to home users in contrast to its use for healthcare professionals only. |
| Oct 18, 2006 | Not classified | Z-0227-2007 | Other | Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips. |
| Mar 28, 2005 | Not classified | Z-0099-06 | Other | Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. |
| Sep 12, 2003 | Not classified | Z-1293-03 | Other | Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch. |
| Feb 20, 2003 | Not classified | Z-0720-03 | Other | Discrepancy between INR and the % Quick displayed on the meter. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974569: Coaguchek System, Coaguchek System for Prothrombin Time Self Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974569
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026