510(k) · Cleared
ClearedHemochron Signature Elite
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 Feb 10, 2005 as substantially equivalent to K020798 (International Technidyne Corp., 2002) after a 37-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 10, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923761 (1993). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923761 Itc Microsample Coagulation Analyzer SystemInternational Technidyne Corp. · 1993
- 2 generations backK974799 Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998 · Recalled
- 1 generation backK020798 Hemochron JR. Signature +International Technidyne Corp. · 2002
- This deviceK050016 Hemochron Signature EliteInternational Technidyne Corp. · 2005
- Descendant · cites it directly · 1 of its ownK193041 Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019
- Descendant · 2 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923761 | Itc Microsample Coagulation Analyzer System | International Technidyne Corp. | 1993 | — |
| −2 | K974799 | Hemochron JR Generation II, Hemochron JR Signature | International Technidyne Corp. | 1998 | 2 |
| −1 | K020798 | Hemochron JR. Signature + | International Technidyne Corp. | 2002 | — |
| 0 (this device) | K050016 | Hemochron Signature Elite | International Technidyne Corp. | 2005 | — |
| +1 | K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K020798 | Hemochron JR. Signature +Summary page 1…evice Substantial equivalence is claimed to the currently marketed International Technidyne Corporation's HEMOCHRON® Jr. Signature+Whole Blood Microcoagulation System (K 020798). Description of Device The HEMOCHRON8' Signature Elite Whole Blood Microcoagulation System is a battery-… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193041 | Hemochron Signature Elite | 2019 | 1 |
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 12 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K193041 (Accriva Diagnostics, Inc., 2019) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The HEMOCHRON® Signature Elite'TM is a battery operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. The system is intended for use in clinical settings requiring point of care coagulation testing. Whole blood test results are displayed as clotting times (in seconds). The HEMOCHRON® Signature Elite' TM also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value.
For in vitro Diagnostic Use Only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050016: Hemochron Signature Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050016
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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