510(k) · Cleared
ClearedHemochron JR. Miocrocoagulation Citrated PT
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 Sep 30, 1998 as substantially equivalent to K940432 (International Technidyne Corp., 1994) after a 422-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 30, 1998
- Review
- 422 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940432 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940432 Microcoagulation Prothrombin Time TestInternational Technidyne Corp. · 1994 · Recalled
- This deviceK972866 Hemochron JR. Miocrocoagulation Citrated PTInternational Technidyne Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940432 | Microcoagulation Prothrombin Time Test | International Technidyne Corp. | 1994 | 2 |
| 0 (this device) | K972866 | Hemochron JR. Miocrocoagulation Citrated PT | International Technidyne Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K940432 | Microcoagulation Prothrombin Time TestSummary page 1…lood Prothrombin Time Test Predicate Device International Technidyne Corporation Hemochron® Jr. Microcoagulation Prothrombin Time Test, which was approved under 510(k), K940432/S1 dated 5/18/94. Device Description The Hemochron® Jr. Microcoagulation Citrated PT test is a self-contained disposable test c… | 1994 |
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?
- Its one ancestor has a recall.
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 | — |
What is it indicated for?
The Hemochrone Jr. Citrated PT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage prothrombin time. The Citrated PT test is performed using a citrated whole blood sample on the Hemochron® Jr. microcoagulation system. The instrument is portable and is intended for point of care testing. The instrument is not intended for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972866 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972866: Hemochron JR. Miocrocoagulation Citrated PT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972866
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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