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 Sep 17, 1999 as substantially equivalent to K955278 (Behring Diagnostics, Inc., 1996) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 17, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926551 (1995). 3 ancestors in all, the oldest K924124 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
- 1 generation backK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
- This deviceK992321 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK993299 Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK162420 Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · cites it directly1descendant
- K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999 · cites it directly1descendant
- K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016 · 2 generations on0descendants
- K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926551 | Behring Fibrintimer a | Behring Diagnostics, Inc. | 1995 | — |
| −1 | K955278 | Behring Coagulation Timer | Behring Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K992321 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 1999 | — |
| +1 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
| +1 | K993299 | Sysmex Automated Coagulation Analyzer, Model CA-1500 | Dade Behring, Inc. | 1999 | — |
| +2 | K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2016 | — |
| +2 | K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540.… | Dade Behring, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K955278 | Behring Coagulation TimerSummary page 1…2517506 The Sysmex® CA-6000 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278; or to the Behring Fibrintimer A (BFA), which was previously cleared under Document Control No. K924124. The Sysmex® CA-6000 is i… | 1996 |
| * | K924124 | Behring Fibrintimer aSummary page 1…er (BCT), which was previously cleared under Document Control No. K955278; or to the Behring Fibrintimer A (BFA), which was previously cleared under Document Control No. K924124. The Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer. 00016 510(k) Summar… | 1992 |
What descends from it? (4)
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K020979 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K955278.
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 intended use of the Sysmex® CA-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
Prothrombin Time (PT) Extrinsic Factors (II, V, VII, X)
Activated Partial Thromboplastin Time (APTT) Intrinsic Factors (VIII, IX, XI, XII)
Fibrinogen (Clauss) Batroxobin
Thrombin Time Protein C
Chromogenic Analysis Parameters
Antithrombin III Protein C
Plasminogen Heparin
Calculated Parameters
PT Ratio Derived Fibrinogen
PTINR
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992321 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992321: Sysmex Automated Coagulation Analyzer, Model CA-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992321
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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