510(k) · Cleared
Recalled · 2011Hemochron JR Generation II, Hemochron JR Signature
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 Jul 7, 1998 as substantially equivalent to K923761 (International Technidyne Corp., 1993) and 1 other predicate after a 197-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 7, 1998
- Review
- 197 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923761 (1993). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923761 Itc Microsample Coagulation Analyzer SystemInternational Technidyne Corp. · 1993
- This deviceK974799 Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998
- Descendant · cites it directly · 3 of its ownK020798 Hemochron JR. Signature +International Technidyne Corp. · 2002
- Descendant · 2 generations on · 2 of its ownK050016 Hemochron Signature EliteInternational Technidyne Corp. · 2005
- Descendant · 3 generations on · 1 of its ownK193041 Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019
- Descendant · 4 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 4 of 4 · See all- K020798Hemochron JR. Signature +International Technidyne Corp. · 2002 · cites it directly3descendants
- K050016Hemochron Signature EliteInternational Technidyne Corp. · 2005 · 2 generations on2descendants
- K193041Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019 · 3 generations on1descendant
- K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923761 | Itc Microsample Coagulation Analyzer System | International Technidyne Corp. | 1993 | — |
| 0 (this device) | K974799 | Hemochron JR Generation II, Hemochron JR Signature | International Technidyne Corp. | 1998 | — |
| +1 | K020798 | Hemochron JR. Signature + | International Technidyne Corp. | 2002 | — |
| +2 | K050016 | Hemochron Signature Elite | International Technidyne Corp. | 2005 | — |
| +3 | K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019 | — |
| +4 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K923761 | Itc Microsample Coagulation Analyzer SystemSummary page 1…RON® Jr. Generation II HEMOCHRON® Jr. Signature Predicate Device International Technidyne Corp. HEMOCHRON® Jr. Microcoagulation System which was approved under 510 (k) K923761/A (APTT only, January 21, 1993) and K940401 (multiple assay use May 11, 1994). Device Description The Generation II system perf… | 1993 |
| * | K940401 | JR. Microcoagulation SystemSummary page 1…ture Predicate Device International Technidyne Corp. HEMOCHRON® Jr. Microcoagulation System which was approved under 510 (k) K923761/A (APTT only, January 21, 1993) and K940401 (multiple assay use May 11, 1994). Device Description The Generation II system performs the same tests as the predicate Jr. sys… | 1994 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020798 | Hemochron JR. Signature + | 2002 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2011 | Not classified | Z-2954-2011 | Device Design | Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments. |
| May 10, 2011 | Not classified | Z-2953-2011 | Device Design | Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K020798 (International Technidyne Corp., 2002) has gone furthest, with 3 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 | — |
What is it indicated for?
The portable, battery operated HEMOCHRON® JR. SIGNATURE is a microcoagulation instrument designed to perform whole blood coagulation tests using fresh whole blood at the patient bedeside. The sgystem is intended to be used in many clinical gettings requiring point-of-care testing. Whole blood test reaults are displayed as clotting times, in sgeconds. The instrument also displays correlated celite equivalent values. The correlated values are based on regression analyses of comparative whole blood/plasma studies.
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/K974799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974799: Hemochron JR Generation II, Hemochron JR Signature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974799
Report an extraction error
Are you the manufacturer?
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