510(k) · Cleared
ClearedCatalog NO. J-Act+ & QC-Act+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Technidyne Corp. · JBP Activated Whole Blood Clotting Time
Cleared on Jun 30, 1994 after a 121-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 30, 1994
- Review
- 121 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK941007 Catalog NO. J-Act+ & QC-Act+International Technidyne Corp. · 1994
- Descendant · cites it directly · 1 of its ownK120977 Directcheck Control for Hemochron JR. Microcoagulation Systems…International Technidyne Corp. · 2013
- 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 2 of 2 · See all- K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…International Technidyne Corp. · 2013 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K941007 | Catalog NO. J-Act+ & QC-Act+ | International Technidyne Corp. | 1994 | — |
| +1 | K120977 | Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette… | International Technidyne Corp. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 2013 | 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 JBP? 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 JBP device
- #1 K223635 Sonoclot Coagulation & Platelet Function…score 4.6 · 1 generation · no Class I recall
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K120977 (International Technidyne Corp., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JBP devicesJBP Activated Whole Blood Clotting Time: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JBP
Too few JBP 510(k)s in any year since 2007 to give a median.
Recalls per year · JBP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JBP
18in 2025
MAUDE reports naming product code JBP, 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 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 3 | 29 |
| 2010 | 0 | — | 3 | 24 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K941007: Catalog NO. J-Act+ & QC-Act+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K941007
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026