510(k) · Cleared

Cleared

Sysmex Automated Coagulation Analyzer, Model #CA-7000

K020979510(k) TraditionalCleared Jun 27, 200293-day reviewClass II21 CFR 864.5400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · GKP Instrument, Coagulation, Automated

Cleared on Jun 27, 2002 as substantially equivalent to K964139 (Dade Intl., Inc., 1997) and 5 other predicates after a 93-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.

Decided: Jun 27, 2002
Review: 93 days
Class: Class II
Product code: GKP
Recalls: None
Predicates: 6

Its longest line of descent runs back 3 generations to K926551 (1995). 10 ancestors in all, the oldest K894052 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
2 generations backK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
1 generation backK970431 Behring Coagulation SystemBehring Diagnostics, Inc. · 1997 · Recalled
This deviceK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
Descendant · cites it directly · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K926551	Behring Fibrintimer a	Behring Diagnostics, Inc.	1995	—
−2	K955278	Behring Coagulation Timer	Behring Diagnostics, Inc.	1996	—
−1	K970431	Behring Coagulation System	Behring Diagnostics, Inc.	1997	2
0 (this device)	K020979	Sysmex Automated Coagulation Analyzer, Model #CA-7000	Dade Behring, Inc.	2002	—
+1	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
1989	1	0
1992	1	0
1997	1	0
1999	2	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K020979, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K964139	Sysmex CA-6000 Summary page 1 …technological characteristics to the Sysmex@Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and KO01 145; or the Behring Coagulation System (BCSTMSystem), Dade Behring, Marburg, Germany, which was cleare…	Dade Intl., Inc.	1997	—
*	K992321	Sysmex Automated Coagulation Analyzer, Model CA-6000 Summary page 1 …ical characteristics to the Sysmex@Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and KO01 145; or the Behring Coagulation System (BCSTMSystem), Dade Behring, Marburg, Germany, which was cleared by FDA…	Dade Behring, Inc.	1999	—
*	K993174	Sysmex Automated Coagulation Analyzer, Model CA-6000 Summary page 1 …acteristics to the Sysmex@Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and KO01 145; or the Behring Coagulation System (BCSTMSystem), Dade Behring, Marburg, Germany, which was cleared by FDA under Doc…	Dade Behring, Inc.	1999	—
*	K001145	Sysmex Automated Coagulation Analyzer, Model CA-6000	Dade Behring, Inc.	2000	—
*	K970431	Behring Coagulation System Summary page 1 …139, K992321, K993174 and KO01 145; or the Behring Coagulation System (BCSTMSystem), Dade Behring, Marburg, Germany, which was cleared by FDA under Document Control Nos. K97043 1 and K000973. As demonstrated by clinical correlation studies, the perEormance claims of the proposed device are similar to the p…	Behring Diagnostics, Inc.	1997	2
*	K000973	Behring Coagulation System (BCS) Summary page 1 …K993174 and KO01 145; or the Behring Coagulation System (BCSTMSystem), Dade Behring, Marburg, Germany, which was cleared by FDA under Document Control Nos. K97043 1 and K000973. As demonstrated by clinical correlation studies, the perEormance claims of the proposed device are similar to the predicate dev…	Dade Behring, Inc.	2000	—

Also cleared against K964139: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031377	Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…	Dade Behring, Inc.	2003	0

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 7 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
1 of the 10 ancestors has a recall of any class.
Of its descendants, K031377 (Dade Behring, Inc., 2003) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K964139.

How does its category compare?

All GKP devices

GKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKP

1in 2024

2007high 1 (2007) · low 0 (2010)2026

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

2007high 4 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GKP

5in 2024

2007high 190 (2009) · low 0 (2025)2025

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-7000 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 coagulation tests.

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/K020979 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020979

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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