510(k) · Cleared
Recalled · 2007Coaguchek PST System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · GJS Test, Time, Prothrombin
Cleared on Apr 22, 1997 after a 295-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 22, 1997
- Review
- 295 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 4
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK962571 Coaguchek PST SystemBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 3 of its ownK030845 Coaguchek PT.S Test for Prothrombin Time Self-TestingRoche Diagnostics Corp. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK093243 Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK183255 Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK212779 Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient…Coagusense, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K030845Coaguchek PT.S Test for Prothrombin Time Self-TestingRoche Diagnostics Corp. · 2003 · cites it directly3descendants
- K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · 2 generations on2descendants
- K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · 3 generations on1descendant
- K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962571 | Coaguchek PST System | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K030845 | Coaguchek PT.S Test for Prothrombin Time Self-Testing | Roche Diagnostics Corp. | 2003 | 1 |
| +2 | K093243 | Coagusense Self-Test Prothrombin Time/Inr Monitoring System | Coagusense, Inc. | 2010 | 1 |
| +3 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019 | 1 |
| +4 | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 GJS? 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 |
|---|---|---|---|
| * | — | Boehringer Mannheim CoaguChek System Named without a submission number | |
| † | K930454 | Boehringer Mannheim Coaguchek System | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030845 | Coaguchek PT.S Test for Prothrombin Time Self-Testing | 2003 | 3 |
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-0098-06 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030845 (Roche Diagnostics Corp., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.
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/K962571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962571: Coaguchek PST System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962571
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