510(k) · Cleared
Recalled · Class II · 2013Protime Microcoagulation System / Protime 3 Cuvette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Technidyne Corp. · GJS Test, Time, Prothrombin
Cleared on Jul 2, 2001 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 21 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 2, 2001
- Review
- 124 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 3
- Predicates
- 0
20 later devices descend from it, 2 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.
- This deviceK010599 Protime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. · 2001
- Descendant · cites it directly · 18 of its ownK020831 PT S Test Strips and Controls for the Coaguchek S System, Models…Roche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 16 of its ownK060978 Coaguchek XS SystemRoche Diagnostics · 2006 · Recalled
- Descendant · 3 generations on · 6 of its ownK071041 Coaguchek XS Plus SystemRoche Diagnostics · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK180780 microINR SystemIline Microsystems, S.L. · 2019
- Descendant · 4 generations on · 3 of its ownK201185 microINR SystemIline Microsystems, S.L. · 2020
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K020831PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404Roche Diagnostics Corp. · 2002 · cites it directly18descendants
- K060978Coaguchek XS SystemRoche Diagnostics · 2006 · 2 generations on16descendants
- K071041Coaguchek XS Plus SystemRoche Diagnostics · 2007 · 3 generations on6descendants
- K180780microINR SystemIline Microsystems, S.L. · 2019 · 3 generations on4descendants
- K201185microINR SystemIline Microsystems, S.L. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010599 | Protime Microcoagulation System / Protime 3 Cuvette | International Technidyne Corp. | 2001 | — |
| +1 | K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… | Roche Diagnostics Corp. | 2002 | — |
| +2 | K060978 | Coaguchek XS System | Roche Diagnostics | 2006 | 3 |
| +3 | K071041 | Coaguchek XS Plus System | Roche Diagnostics | 2007 | Class I |
| +3 | K180780 | microINR System | Iline Microsystems, S.L. | 2019 | — |
| +4 | K201185 | microINR System | Iline Microsystems, S.L. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 1 |
| 2010 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2018 | 2 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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 16, 2013 | Class II | Z-2198-2013 | Storage | The products may have been stored at temperatures outside their required storage conditions. |
| Sep 28, 2012 | Class II | Z-0837-2013 | Process change control | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. |
| Nov 19, 2007 | Not classified | Z-0546-2008 | Device Design | An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages. |
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.
- K071041Coaguchek XS Plus SystemRoche Diagnostics · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K170960CoaguChek Vantus SystemRoche Diagnostics · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K180684CoaguChek XS Plus SystemRoche Diagnostics · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K093460Coaguchek XS Pro SystemRoche Diagnostics · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020831 (Roche Diagnostics Corp., 2002) has gone furthest, with 18 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 | — |
https://510kreport.com/device/K010599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010599: Protime Microcoagulation System / Protime 3 Cuvette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010599
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026