510(k) · Cleared
ClearedSysmex Automated Coagulation Analyzer, Model CA-6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GKP Instrument, Coagulation, Automated
Cleared on May 11, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 11, 2000
- Review
- 31 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK001145 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK013114 BCS SystemDade Behring, Inc. · 2001 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · cites it directly1descendant
- K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc. · 2003 · 2 generations on0descendants
- K013114BCS SystemDade Behring, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001145 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 2000 | — |
| +1 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
| +2 | K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540.… | Dade Behring, Inc. | 2003 | — |
| +1 | K013114 | BCS System | Dade Behring, Inc. | 2001 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020979 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K001145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001145: Sysmex Automated Coagulation Analyzer, Model CA-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001145
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026