510(k) · Cleared
ClearedAutomated Blood Coagulation Analyzer CS-2500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostic Products GmbH · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 18, 2017 as substantially equivalent to K011235 (Dade Behring, Inc., 2001) after a 143-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 18, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011235 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011235 Sysmex Automated Coagulation Analyzer / Model # CA-1500Dade Behring, Inc. · 2001
- This deviceK172286 Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011235 | Sysmex Automated Coagulation Analyzer / Model # CA-1500 | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | 2017 | — |
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 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 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K011235 | Sysmex Automated Coagulation Analyzer / Model # CA-1500Summary page 5…t Code: JPA 510(k) Review Panel Hematology 3 Predicate Device Name of Device: Sysmex® CA-1500 (K011235) Common or Usual Name: Automated Coagulation Instrument Classification Name: Multipurpos… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 7 other devices also cite its predicate K011235.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Sysmex® Automated Blood Coagulation Analyzer CS-2500 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of: • Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® • Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL…
Read the full statement (330 words)
The Sysmex® Automated Blood Coagulation Analyzer CS-2500 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.
For determination of:
• Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
• Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Coagulation Factor V with Dade® Innovin®
• Coagulation Factor VII with Dade® Innovin®
• Coagulation Factor VIII with Dade® Actin® FSL
• Coagulation Factor IX with Dade® Actin® FSL
• Lupus Anticoagulant with LA1 Screening / LA2 Confirmation Reagent
• Factor V Leiden with Factor V Leiden Assay
• Protein C with Protein C Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• Protein C with Berichrom® Protein C
• D-dimer with INNOVANCE® D-Dimer
The performance of this device has not been established in neonate and pediatric patient populations.
Intended Use for Factor V Leiden Assay:
The Siemens Healthcare Diagnostics Factor V Leiden Assay is a simple functional clotting test system intended for screening of resistance to Activated Protein C (APC) in plasma from individuals with Factor V (Leiden) defect. For in vitro diagnostic use.
Intended Use for Coagulation Factor VIII Deficient Plasma:
In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods.
Intended Use for Coagulation Factor IX Deficient Plasma:
In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods.
Intended Use for LA1 Screening / LA2 Confirmation Reagents:
LA1 Screening Reagent / LA2 Confirmation Reagent are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. LA1 Screening Reagent: Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants. LA2 Confirmation Reagent: Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172286: Automated Blood Coagulation Analyzer CS-2500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172286
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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