510(k) · Cleared
Recalled · Class II · 2026JR. Microcoagulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Technidyne Corp. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on May 11, 1994 after a 104-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- May 11, 1994
- Review
- 104 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 3
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK940401 JR. Microcoagulation SystemInternational Technidyne Corp. · 1994
- Descendant · cites it directly · 4 of its ownK974799 Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998 · Recalled
- Descendant · 2 generations on · 3 of its ownK020798 Hemochron JR. Signature +International Technidyne Corp. · 2002
- Descendant · 3 generations on · 2 of its ownK050016 Hemochron Signature EliteInternational Technidyne Corp. · 2005
- Descendant · 4 generations on · 1 of its ownK193041 Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019
- Descendant · 5 generations on · 0 of its ownK202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time…Accriva Diagnostics, Inc. · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K974799Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998 · cites it directly4descendants
- K020798Hemochron JR. Signature +International Technidyne Corp. · 2002 · 2 generations on3descendants
- K050016Hemochron Signature EliteInternational Technidyne Corp. · 2005 · 3 generations on2descendants
- K193041Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019 · 4 generations on1descendant
- K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940401 | JR. Microcoagulation System | International Technidyne Corp. | 1994 | — |
| +1 | K974799 | Hemochron JR Generation II, Hemochron JR Signature | International Technidyne Corp. | 1998 | 2 |
| +2 | K020798 | Hemochron JR. Signature + | International Technidyne Corp. | 2002 | — |
| +3 | K050016 | Hemochron Signature Elite | International Technidyne Corp. | 2005 | — |
| +4 | K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019 | — |
| +5 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test… | Accriva Diagnostics, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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.
Planning a device in JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974799 | Hemochron JR Generation II, Hemochron JR Signature | 1998 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2026 | Not classified | Z-0317-2027 | Process control | Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or… |
| Apr 22, 2016 | Class II | Z-1720-2016 | Process design | Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result. |
| Jun 20, 2014 | Class II | Z-2088-2014 | Device Design | Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K974799 (International Technidyne Corp., 1998) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K940401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940401: JR. Microcoagulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940401
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026