510(k) · Cleared
ClearedCoag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coagusense, Inc. · GJS Test, Time, Prothrombin
Cleared on Oct 5, 2022 as substantially equivalent to K183255 (Coagusense, Inc., 2019) after a 399-day review. Its family tree reaches back 4 generations to 1997. 3 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 5, 2022
- Review
- 399 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962571 (1997). 8 ancestors in all. No later device cites it as a predicate yet. 3 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962571 Coaguchek PST SystemBoehringer Mannheim Corp. · 1997 · Recalled
- 3 generations backK030845 Coaguchek PT.S Test for Prothrombin Time Self-TestingRoche Diagnostics Corp. · 2003 · Recalled
- 2 generations backK093243 Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · Recalled
- 1 generation backK183255 Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · Recalled
- This deviceK212779 Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient…Coagusense, Inc. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962571 | Coaguchek PST System | Boehringer Mannheim Corp. | 1997 | 4 |
| −3 | 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 |
| −1 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019 | 1 |
| 0 (this device) | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 2 |
| 2005 | 1 | 0 |
| 2007 | 1 | 1 |
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.
3 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 |
|---|---|---|---|
| * | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceSummary page 4…Number Coag-Sense Prothrombin Time (PT)/INR System CoaguSense Inc. K183255 For Patient Self-Testing CoaguSense, Inc. Appendix 2 - 1 === Page… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K072727Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 14 Class I recalls
- K021923Inratio Self-TestHemosense, Inc. · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K020679InratioHemosense, Inc. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 7 of the 8 ancestors have a recall of any class; 3 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. 2022, 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 Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood. The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to…
Read the full statement (131 words)
The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood.
The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.
The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes.
The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient 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/K212779
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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