510(k) · Cleared
Recalled · 2010Acl Elite; Acl Elite Pro
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 Feb 21, 2006 as substantially equivalent to K000053 (Instrumentation Laboratory CO, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 5 times.
- Decided
- Feb 21, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000053 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000053 Acl 9000 SystemInstrumentation Laboratory CO · 2000
- This deviceK060162 Acl Elite; Acl Elite ProInstrumentation Laboratory CO · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000053 | Acl 9000 System | Instrumentation Laboratory CO | 2000 | — |
| 0 (this device) | K060162 | Acl Elite; Acl Elite Pro | Instrumentation Laboratory CO | 2006 | — |
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 |
|---|---|---|---|
| * | K000053 | Acl 9000 SystemSummary page 1…system for in vitro coagulation studies (864.5425) Classification: Class II Product Code: JPA Panel: Hematology Legally Marketed Device: K000053 ACL 9000 (ACL 8000 and ACL 10000) Device Description: The ACL Elite and ACL Elite Pro are fully automated, high-p… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2010 | Not classified | Z-0805-2011 | Device Design | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
| Nov 11, 2010 | Not classified | Z-0806-2011 | Device Design | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
| Nov 11, 2010 | Not classified | Z-0807-2011 | Device Design | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
| Nov 11, 2010 | Not classified | Z-0803-2011 | Device Design | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
| Nov 11, 2010 | Not classified | Z-0804-2011 | Device Design | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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 ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060162: Acl Elite; Acl Elite Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060162
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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