510(k) Report

510(k) · Cleared

Cleared

Sysmex Automated Coagulation Analyzer / Model # CA-1500

K011235510(k) TraditionalCleared Jul 20, 200188-day reviewClass II21 CFR 864.5425

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

Dade Behring, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies

Cleared on Jul 20, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Jul 20, 2001
Review
88 days
Class
Class II
Product code
JPA
Recalls
None
Predicates
0

9 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2016: 6 descendants cleared2017: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK011235 Sysmex Automated Coagulation Analyzer / Model # CA-1500Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK150678 Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH · 2016
  3. Descendant · 2 generations on · 0 of its ownK250965 Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc. · 2025
  4. Descendant · cites it directly · 0 of its ownK172286 Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH · 2017
  5. Descendant · cites it directly · 0 of its ownK172333 Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH · 2017
  6. Descendant · cites it directly · 0 of its ownK162688 Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH · 2016

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2016: 62017: 22025: 1
2016high 6 (2016) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH · 2016 · cites it directly1descendant
  • K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc. · 2025 · 2 generations on0descendants
  • K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH · 2017 · cites it directly0descendants
  • K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH · 2017 · cites it directly0descendants
  • K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011235Sysmex Automated Coagulation Analyzer / Model # CA-1500Dade Behring, Inc.2001—
+1K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH2016—
+2K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.2025—
+1K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH2017—
+1K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH2017—
+1K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201660
201720
202510
FIG. 1 — Lineage of K011235, 2001–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JPA? 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 JPA device

  1. #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (9)

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

NumberDeviceApplicantDecidedDescendants
K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH20161
K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH20170
K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH20170
K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH20160
K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH20160
K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH20160
K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH20160
K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH20160

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, K150678 (Siemens Healthcare Diagnostic Products GmbH, 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JPA devices

JPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPA

3in 2025

2007: 12008: 22009: 62010: 12011: 12013: 12015: 22016: 62017: 42018: 12019: 32021: 12022: 12023: 32024: 12025: 32026 (partial year): 1
2007high 6 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPA

30in 2025

2009: 91 days median2016: 114 days median2017: 117 days median2019: 175 days median2023: 506 days median2025: 30 days median
2007high 506 (2023) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPA

1in 2020

2007: 12010: 62011: 42012: 12016: 32020: 12026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JPA

11in 2025

2007: 1,7442008: 9182009: 1,3632010: 7272011: 1612012: 522013: 432014: 482015: 452016: 62017: 152018: 392019: 272020: 182021: 72022: 92023: 112024: 82025: 11
2007high 1,744 (2007) · low 6 (2016)2025

MAUDE reports naming product code JPA, 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—11,744
20082—0918
200969101,363
20101—6727
20111—4161
20120—152
20131—043
20140—048
20152—045
2016611436
20174117015
20181—039
20193175027
20200—118
20211—07
20221—09
20233506011
20241—08
2025330011
20261—1—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JPA

The JPA category page

  • K253658STA Satellite Max®Diagnostica Stago, Inc. · 2026
  • K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc. · 2025
  • K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics · 2025
  • K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025
  • K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation · 2024

https://510kreport.com/device/K011235 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011235: Sysmex Automated Coagulation Analyzer / Model # CA-1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011235

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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