510(k) · Cleared
Recalled · Class II · 2022Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GKP Instrument, Coagulation, Automated
Cleared on Mar 3, 2016 as substantially equivalent to K073377 (Instrumentation Laboratory CO, 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- GKP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002400 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 4 generations backK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004 · Recalled
- 3 generations backK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- 2 generations backK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- 1 generation backK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- This deviceK160276 Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500…Instrumentation Laboratory CO · 2016
- Descendant · cites it directly · 0 of its ownK183390 QNext and DG-PTDiagnostic Grifols, S.A. · 2019
- Descendant · cites it directly · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −4 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| −3 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| −2 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| −1 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| 0 (this device) | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl… | Instrumentation Laboratory CO | 2016 | — |
| +1 | K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | 2019 | — |
| +1 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
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 GKP? 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 GKP device
- #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K073377 | Acl Top (with System Software V3.0.0)Summary page 4…Panel: Hematology (81) Product Code: GKP Predicate Device ACL TOP: K073377; K091980 (LAS model) Device Indications for Use / The ACL TOP is a bench top, fully automated, random access Intended Us… | 2008 |
| * | K091980 | Acl Top 700 LasSummary page 4…Panel: Hematology (81) Product Code: GKP Predicate Device ACL TOP: K073377; K091980 (LAS model) Device Indications for Use / The ACL TOP is a bench top, fully automated, random access Intended Use… | 2009 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2022 | Class II | Z-1014-2022 | Under Investigation by firm | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K183390 (Diagnostic Grifols, S.A., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073377.
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GKP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKP
Too few GKP 510(k)s in any year since 2007 to give a median.
Recalls per year · GKP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKP
5in 2024
MAUDE reports naming product code GKP, 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 | — | 3 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 190 |
| 2010 | 0 | — | 4 | 74 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 24 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACL TOP is a bench top, fully automated, random access analyzer 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 system provides results for both direct hemostasis measurements and calculated parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160276
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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