510(k) · Cleared
Recalled · Class I · 2016Inratio 2 PT Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemosense, Inc. · GJS Test, Time, Prothrombin
Cleared on Oct 26, 2007 as substantially equivalent to K020679 (Hemosense, Inc., 2002) after a 30-day review. Its family tree reaches back 1 generation to 2002. 4 of the 7 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 6 times, including 4 Class I recalls.
- Decided
- Oct 26, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 6 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020679 (2002). 5 later devices descend from it, 3 citing it directly. 4 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK020679 InratioHemosense, Inc. · 2002 · Recalled (Class I)
- This deviceK072727 Inratio 2 PT Monitoring SystemHemosense, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK093243 Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK183255 Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK092987 Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK212779 Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient…Coagusense, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK110212 INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 2010 · cites it directly2descendants
- K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 2019 · 2 generations on1descendant
- K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010 · cites it directly1descendant
- K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc. · 2022 · 3 generations on0descendants
- K110212INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020679 | Inratio | Hemosense, Inc. | 2002 | Class I |
| 0 (this device) | K072727 | Inratio 2 PT Monitoring System | Hemosense, Inc. | 2007 | — |
| +1 | K093243 | Coagusense Self-Test Prothrombin Time/Inr Monitoring System | Coagusense, Inc. | 2010 | 1 |
| +2 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019 | 1 |
| +1 | K092987 | Inratio/INRATIO2 Test Strips | Biosite Incorporated | 2010 | Class I |
| +3 | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022 | — |
| +1 | K110212 | INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip | Alere San Diego, Inc (Formally Biosite Incorporate | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 1 |
| 2012 | 1 | 1 |
| 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.
4 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 |
|---|---|---|---|
| * | K020679 | InratioSummary page 1…Prothrombin Time Test Proprietary name FNRatio® 2 PT Monitoring System C. Predicate Device: INRatio® System, K020679 D. Device Description: Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of… | 2002 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2016 | Class I | Z-2357-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR… |
| Jul 11, 2016 | Class I | Z-2360-2016 | Other | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR… |
| Dec 5, 2014 | Class I | Z-0880-2015 | Under Investigation by firm | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical… |
| Dec 5, 2014 | Class I | Z-0882-2015 | Under Investigation by firm | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical… |
| Oct 11, 2011 | Not classified | Z-0188-2012 | Material/Component Contamination | Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus. |
| Dec 23, 2008 | Not classified | Z-1256-2009 | Nonconforming Material/Component | INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K020679InratioHemosense, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K110212INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072727: Inratio 2 PT Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072727
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