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 Nov 9, 1999 as substantially equivalent to K955278 (Behring Diagnostics, Inc., 1996) after a 48-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 9, 1999
- Review
- 48 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926551 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
- 1 generation backK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
- This deviceK993174 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 · 2 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
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 |
|---|---|---|---|---|---|
| −2 | K926551 | Behring Fibrintimer a | Behring Diagnostics, Inc. | 1995 | — |
| −1 | K955278 | Behring Coagulation Timer | Behring Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K993174 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 1999 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | 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. The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer. 0016 510(k… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | 2002 | 1 |
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 3.4 years on median.
- None of the 2 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
Factor VIII; a2-Antiplasmin
Calculated Parameters
PT Ratio; Derived Fibrinogen
PTINR; Factor Assays % Activity
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/K993174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993174: 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/K993174
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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