510(k) · Cleared
ClearedAcl Top 970 CL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 29, 2023 as substantially equivalent to K150877 (Instrumentation Laboratory CO, 2015) after a 31-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 29, 2023
- Review
- 31 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002400 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 5 generations backK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004 · Recalled
- 4 generations backK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- 3 generations backK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- 2 generations backK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- 1 generation backK150877 Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top…Instrumentation Laboratory CO · 2015 · Recalled
- This deviceK233790 Acl Top 970 CLInstrumentation Laboratory · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −5 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| −4 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| −3 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| −2 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| −1 | K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl… | Instrumentation Laboratory CO | 2015 | 1 |
| 0 (this device) | K233790 | Acl Top 970 CL | Instrumentation Laboratory | 2023 | — |
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 |
|---|---|---|---|
| * | K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…Summary page 4…erfen.com Preparation Date December 29, 2023 Device Trade Name ACL TOP 970 CL Predicate Device ACL TOP Family 50 Series K150877 Regulation Section No. 21 CFR 864.5425… | 2015 |
| † | K231031 | ACL TOP Family 70 Series | 2023 |
| † | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | 2023 |
| † | K172903 | HemosIL D-Dimer HS 500 | 2017 |
| † | K034007 | Hemosil Factor Viii Deficient Plasma | 2004 |
| † | K070005 | Hemosil Recombiplastin 2G | 2007 |
| † | K213464 | HemosIL Liquid Anti-Xa | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150877.
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. 2023, this device’s year, is highlighted.
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 TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct measurements and calculated parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233790 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233790: Acl Top 970 CL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233790
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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