510(k) · Cleared
Recalled · 2005Modification of Acl Advance
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 Aug 30, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 30, 2000
- Review
- 26 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 0
48 later devices descend from it, 14 citing it directly.
- This deviceK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000
- Descendant · cites it directly · 18 of its ownK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004 · Recalled
- Descendant · 2 generations on · 12 of its ownK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 3 generations on · 11 of its ownK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- Descendant · 4 generations on · 7 of its ownK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- Descendant · cites it directly · 7 of its ownK030965 Control Plasma LMW HeparinInstrumentation Laboratory CO · 2003
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K033414Acl Top Model, TopInstrumentation Laboratory CO · 2004 · cites it directly18descendants
- K063679Acl TopInstrumentation Laboratory CO · 2007 · 2 generations on12descendants
- K073377Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008 · 3 generations on11descendants
- K091980Acl Top 700 LasInstrumentation Laboratory CO · 2009 · 4 generations on7descendants
- K030965Control Plasma LMW HeparinInstrumentation Laboratory CO · 2003 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | — |
| +1 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| +2 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| +3 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| +4 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| +1 | K030965 | Control Plasma LMW Heparin | Instrumentation Laboratory CO | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 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? (48)
See all 4814 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033414 | Acl Top Model, Top | 2004 | 18 |
| K030965 | Control Plasma LMW Heparin | 2003 | 7 |
| K030964 | Calibration Plasma LMW Heparin | 2003 | 7 |
| K041905 | Hemosil Calibration Plasma | 2004 | 4 |
| K043184 | Hemosil Recombiplastin | 2004 | 3 |
| K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) | 2002 | 3 |
| K034007 | Hemosil Factor Viii Deficient Plasma | 2004 | 2 |
| K031829 | Hemosil Factor IX Deficient Plasma | 2003 | 2 |
| K043459 | Hemosil Factor Xii Deficient Plasma | 2005 | 1 |
| K050661 | Hemosil Factor II Deficient Plasma | 2005 | 0 |
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-0737-04 | 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, K033414 (Instrumentation Laboratory CO, 2004) has gone furthest, with 18 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/K002400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002400: Modification of Acl Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002400
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026