510(k) Report

510(k) · Cleared

Cleared

Sysmex CA-6000

K964139510(k) TraditionalCleared Feb 6, 1997114-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 Intl., Inc. · GKP Instrument, Coagulation, Automated

Cleared on Feb 6, 1997 as substantially equivalent to K894052 (Medical Laboratory Automation Systems, Inc., 1989) after a 114-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided
Feb 6, 1997
Review
114 days
Class
Class II
Product code
GKP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K894052 (1989). 7 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2001: 1 descendant cleared1999: 2 descendants cleared2003: 1 descendant cleared1998: 1 descendant cleared2016: 1 descendant clearedK894052 · Electra 1000C Automatic Coagulation Timer · Medical Laboratory Automation Systems, Inc. · 19891990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 1 descendant K894052 · Electra 1000C Automatic Coagulation Timer · Medical Laboratory Automation Systems, Inc. · 19890
  1. Root · 1 generation backK894052 Electra 1000C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc. · 1989
  2. This deviceK964139 Sysmex CA-6000Dade Intl., Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
  4. Descendant · cites it directly · 1 of its ownK993299 Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999
  5. Descendant · 2 generations on · 0 of its ownK162420 Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016
  6. Descendant · cites it directly · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
  7. Descendant · cites it directly · 0 of its ownK011665 BCT SystemDade Behring, Inc. · 2001 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22001: 12002: 12003: 12016: 1
1998high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · 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 · cites it directly0descendants
  • K011665BCT SystemDade Behring, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894052Electra 1000C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc.1989—
0 (this device)K964139Sysmex CA-6000Dade Intl., Inc.1997—
+1K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc.2002—
+1K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc.1999—
+2K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH2016—
+1K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540.…Dade Behring, Inc.2003—
+1K011665BCT SystemDade Behring, Inc.20011

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200110
200210
200310
201610
FIG. 1 — Lineage of K964139, 1989–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K894052Electra 1000C Automatic Coagulation Timer
Summary page 1
…to the Electra 1000C™ Automatic Coagulation Timer, manufactured by Medical Laboratory Automation, Inc., Pleasntville, NY, previously cleared under Document Control No., K894052. Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer. 01l 510(k) Summary of S…
Medical Laboratory Automation Systems, Inc.1989—

Also cleared against K894052: 2 other devices →

What descends from it? (7)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc.20021
K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc.19991
K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc.20030
K011665BCT SystemDade Behring, Inc.20010
K984501Dade Behring BftiiDade Behring, Inc.19990
K981711Sysmex Automated Coagulation Analyzer CA-500Dade Behring, Inc.19980

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?

  • Its one ancestor has no recall.
  • Of its descendants, K020979 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K894052.

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

2007: 12008: 12009: 12015: 12016: 12023: 12024: 1
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

2007: 32010: 42022: 1
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

2007: 32008: 52009: 1902010: 742011: 452012: 352013: 422014: 262015: 242016: 132017: 182018: 192019: 382020: 142021: 172022: 42023: 42024: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—33
20081—05
20091—0190
20100—474
20110—045
20120—035
20130—042
20140—026
20151—024
20161—013
20170—018
20180—019
20190—038
20200—014
20210—017
20220—14
20231—04
20241—05
20250—00
20260—0—

What is it indicated for?

Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K894052

2 other devices cite the same predicate.

  • K992130Pacific Hemostasis Thromboscreen 400CPacific Hemostasis · 1999
  • K991321Pacific Hemostasis Thromboscreen 200Pacific Hemostasis · 1999

More from Dade Intl., Inc.

58 FDA decisions under this applicant name. See the company

  • P870049/S032Microscan Rapid Gram Positive Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S031Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S030Microscan (R) Rapid Fluorogenic PanelsDade Intl., Inc. · 2000
  • P870049/S029Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999
  • P870049/S028Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999

Recent decisions in GKP

The GKP category page

  • K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co. · 2024
  • K231031ACL TOP Family 70 SeriesInstrumentation Laboratory Company · 2023
  • K160276Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)Instrumentation Laboratory CO · 20161 recall
  • K150877Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750 CTS; Acl Top 750 LasInstrumentation Laboratory CO · 20151 recall
  • K091980Acl Top 700 LasInstrumentation Laboratory CO · 200924 recalls

https://510kreport.com/device/K964139 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964139: Sysmex 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/K964139

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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