510(k) · Cleared
ClearedmicroINR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iline Microsystems, S.L. · GJS Test, Time, Prothrombin
Cleared on Jul 21, 2025 as substantially equivalent to K243543 (Iline Microsystems, S.L., 2025) and 1 other predicate after a 60-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jul 21, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010599 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 6 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 5 generations backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- 4 generations backK180780 microINR SystemIline Microsystems, S.L. · 2019
- 3 generations backK201185 microINR SystemIline Microsystems, S.L. · 2020
- 2 generations backK231711 microINR SystemIline Microsystems, S.L. · 2023
- 1 generation backK243543 microINR SystemIline Microsystems, S.L. · 2025
- This deviceK251564 microINR SystemIline Microsystems, S.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −6 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −5 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| −4 | K180780 | microINR System | Iline Microsystems, S.L. | 2019 | — |
| −3 | K201185 | microINR System | Iline Microsystems, S.L. | 2020 | — |
| −2 | K231711 | microINR System | Iline Microsystems, S.L. | 2023 | — |
| −1 | K243543 | microINR System | Iline Microsystems, S.L. | 2025 | — |
| 0 (this device) | K251564 | microINR System | Iline Microsystems, S.L. | 2025 | — |
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? (2)
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 |
|---|---|---|---|
| * | K243543 | microINR SystemSummary page 6…Predicate Devices Predicate Device Name microINR System Common Name Prothrombin time test 510 (k) Number K243543, K180780 Manufacturer iLine Microsystems S.L. 4. DEVICE DESCRIPTION: The microINR System design is mai… | 2025 |
| * | K180780 | microINR SystemSummary page 6…Predicate Devices Predicate Device Name microINR System Common Name Prothrombin time test 510 (k) Number K243543, K180780 Manufacturer iLine Microsystems S.L. 4. DEVICE DESCRIPTION: The microINR System design is maintained u… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microINR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microINR System is intended for use in…
Read the full statement (142 words)
The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for
monitoring oral anticoagulant therapy with warfarin.
The microINR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick.
The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care
settings.
The microINR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication
for at least 6 weeks before starting to use the microINR System.
For self-testing use: The system is intended for properly trained users under specific prescription of a physician.
Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to
warfarin therapy. The microINR System is not intended to be used for screening purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251564: microINR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251564
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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