510(k) · Cleared
ClearedHemochron Signature Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accriva Diagnostics, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Nov 22, 2019 as substantially equivalent to K050016 (International Technidyne Corp., 2005) after a 22-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Nov 22, 2019
- Review
- 22 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923761 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK923761 Itc Microsample Coagulation Analyzer SystemInternational Technidyne Corp. · 1993
- 3 generations backK974799 Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998 · Recalled
- 2 generations backK020798 Hemochron JR. Signature +International Technidyne Corp. · 2002
- 1 generation backK050016 Hemochron Signature EliteInternational Technidyne Corp. · 2005
- This deviceK193041 Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time…Accriva Diagnostics, Inc. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923761 | Itc Microsample Coagulation Analyzer System | International Technidyne Corp. | 1993 | — |
| −3 | K974799 | Hemochron JR Generation II, Hemochron JR Signature | International Technidyne Corp. | 1998 | 2 |
| −2 | K020798 | Hemochron JR. Signature + | International Technidyne Corp. | 2002 | — |
| −1 | K050016 | Hemochron Signature Elite | International Technidyne Corp. | 2005 | — |
| 0 (this device) | K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019 | — |
| +1 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test… | Accriva Diagnostics, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K050016 | Hemochron Signature EliteSummary page 4…Panel: Hematology (81) Product Code: JPA Predicate Device HemochronTM Signature Elite: K050016 Indications for Use / The HemochronTM Signature Elite Whole Blood Intended Use Microcoagulation Syst… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)… | 2021 | 0 |
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 26 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K202101 (Accriva Diagnostics, Inc., 2021) has gone furthest, with 0 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. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.
For in vitro Diagnostic Use. For professional use. Rx only.
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/K193041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193041: Hemochron Signature Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193041
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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