510(k) · Cleared
Recalled · 2007Coaguchek S System, Model 2138280
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Sep 6, 2000 as substantially equivalent to K930454 (Boehringer Mannheim Corp., 1993) after a 258-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 6, 2000
- Review
- 258 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930454 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK930454 Boehringer Mannheim Coaguchek SystemBoehringer Mannheim Corp. · 1993 · Recalled
- This deviceK994349 Coaguchek S System, Model 2138280Roche Diagnostics Corp. · 2000
- Descendant · cites it directly · 0 of its ownK071265 Smartcheck Inr SystemInverness Medical Innovations, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071265Smartcheck Inr SystemInverness Medical Innovations, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930454 | Boehringer Mannheim Coaguchek System | Boehringer Mannheim Corp. | 1993 | 3 |
| 0 (this device) | K994349 | Coaguchek S System, Model 2138280 | Roche Diagnostics Corp. | 2000 | — |
| +1 | K071265 | Smartcheck Inr System | Inverness Medical Innovations, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
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
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 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 |
|---|---|---|---|
| * | K930454 | Boehringer Mannheim Coaguchek SystemSummary page 1…m Common name: prothrombin time test Classification name: Prothrombin time test We claim substantial equivalence to the Roche Diagnostics Corporation CoaguChek System, K930454. Continued on next page 27 510(k) Summary Continued 4) Device Description 5) Intended use 6) Comparison to p… | 1993 |
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 |
|---|---|---|---|
| K071265 | Smartcheck Inr System | 2007 | 0 |
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-0100-06 | Other | Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K071265 (Inverness Medical Innovations, Inc., 2007) has gone furthest, with 0 descendants of its own.
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 S System is used for the quantitative determination of prothrombin time (PT) in
fresh capillary or venous whole blood by professional health care providers.
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/K994349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994349: Coaguchek S System, Model 2138280.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994349
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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