510(k) · Cleared
Recalled · 2005Acl Top Model, Top
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 Jan 12, 2004 as substantially equivalent to K002400 (Instrumentation Laboratory CO, 2000) after a 77-day review. Its family tree reaches back 1 generation to 2000. 18 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- GKP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002400 (2000). 18 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- This deviceK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 12 of its ownK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 2 generations on · 11 of its ownK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- Descendant · 3 generations on · 7 of its ownK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- Descendant · 3 generations on · 3 of its ownK150877 Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top…Instrumentation Laboratory CO · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K063679Acl TopInstrumentation Laboratory CO · 2007 · cites it directly12descendants
- K073377Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008 · 2 generations on11descendants
- K091980Acl Top 700 LasInstrumentation Laboratory CO · 2009 · 3 generations on7descendants
- K150877Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…Instrumentation Laboratory CO · 2015 · 3 generations on3descendants
- K043184Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| 0 (this device) | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | — |
| +1 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| +2 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| +3 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| +3 | K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl… | Instrumentation Laboratory CO | 2015 | 1 |
| +1 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K002400 | Modification of Acl AdvanceSummary page 1…for In Vitro Coagulation Studies 864.5425 Multipurpose system for In Vitro Coagulation Studies Class II Identification of predicate device(s): K002400 ACL Advance Description of the device/intended use(s): The ACL TOP is a bench top, fully automated, random access anal… | 2000 |
What descends from it? (18)
See all 183 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K033414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033414: Acl Top Model, Top.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033414
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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