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 Jan 25, 2019 as substantially equivalent to K060978 (Roche Diagnostics, 2006) after a 305-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Jan 25, 2019
- Review
- 305 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010599 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001 · Recalled
- 2 generations backK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- 1 generation backK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- This deviceK180780 microINR SystemIline Microsystems, S.L. · 2019
- Descendant · cites it directly · 3 of its ownK201185 microINR SystemIline Microsystems, S.L. · 2020
- Descendant · 2 generations on · 2 of its ownK231711 microINR SystemIline Microsystems, S.L. · 2023
- Descendant · cites it directly · 1 of its ownK243543 microINR SystemIline Microsystems, S.L. · 2025
- Descendant · cites it directly · 0 of its ownK251564 microINR SystemIline Microsystems, S.L. · 2025
Most influential descendants
Showing 4 of 4 · See all- K201185microINR SystemIline Microsystems, S.L. · 2020 · cites it directly3descendants
- K231711microINR SystemIline Microsystems, S.L. · 2023 · 2 generations on2descendants
- K243543microINR SystemIline Microsystems, S.L. · 2025 · cites it directly1descendant
- K251564microINR SystemIline Microsystems, S.L. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | 3 |
| −2 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| −1 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| 0 (this device) | K180780 | microINR System | Iline Microsystems, S.L. | 2019 | — |
| +1 | 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 | — |
| +1 | K251564 | microINR System | Iline Microsystems, S.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K060978 | Coaguchek XS SystemSummary page 5…Predicate Device Predicate Device Name CoaguChek® XS System Common Name Prothrombin time test 510 (k) Number k060978 Manufacturer Roche Diagnostics 4. DEVICE DESCRIPTION: The microINR® System is comprised of a port… | 2006 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K201185 (Iline Microsystems, S.L., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K060978.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
microINR System: The microINR System (consisting of the microINR Meter and the microINR Chip) is intended for multiple-patient use by professional healthcare providers for the determination of International Normalized Ratio (INR) to monitor Oral Anticoagulation Therapy (OAT) warfarin. The microINR System uses fresh capillary whole blood. The microINR System is intended for in vitro diagnostic use at the point-of-care. The microINR System is intended for…
Read the full statement (190 words)
microINR System:
The microINR System (consisting of the microINR Meter and the microINR Chip) is intended for multiple-patient use by professional healthcare providers for the determination of International Normalized Ratio (INR) to monitor Oral Anticoagulation Therapy (OAT) warfarin. The microINR System uses fresh capillary whole blood. The microINR System is intended for in vitro diagnostic use at the point-of-care.
The microINR System is intended for use in patients 18 years of age and older. Patients must be stabilized (≥ 6 weeks) on warfarin.
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.
The microINR chips are only intended to be used with the microINR meter.
microINR Control Level A / microINR Control Level B:
The microINR Control is intended for quality control performed on the microINR Meter when used with the disposable microINR Chips.
iLine Microsystems has available two microINR Control Levels (A and B) to perform quality control checks in the therapeutic range on the microINR System.
The microINR Control is intended for professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180780: microINR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180780
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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