510(k) · Cleared
Recalled · 2005Acl Futura Coagulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Nov 3, 1995 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 3, 1995
- Review
- 193 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK951891 Acl Futura Coagulation SystemInstrumentation Laboratory CO · 1995
- Descendant · cites it directly · 3 of its ownK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · Recalled
- Descendant · 4 generations on · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
- Descendant · cites it directly · 0 of its ownK973306 IL Test Aptt-SPInstrumentation Laboratory CO · 1997
Most influential descendants
Showing 5 of 5 · See all- K043184Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · cites it directly3descendants
- K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · 2 generations on2descendants
- K122584Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · 3 generations on1descendant
- K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022 · 4 generations on0descendants
- K973306IL Test Aptt-SPInstrumentation Laboratory CO · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951891 | Acl Futura Coagulation System | Instrumentation Laboratory CO | 1995 | — |
| +1 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
| +2 | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | 1 |
| +3 | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | 4 |
| +4 | K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022 | — |
| +1 | K973306 | IL Test Aptt-SP | Instrumentation Laboratory CO | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2005 | Not classified | Z-0915-05 | Other | Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy |
| Mar 4, 2004 | Not classified | Z-0736-04 | Other | Software may cause instrument to omit step causing reagent carrover which may effect patient test result |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043184 (Instrumentation Laboratory CO, 2004) 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 | — |
https://510kreport.com/device/K951891 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951891: Acl Futura Coagulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951891
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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