510(k) · Cleared
ClearedSysmex Automated Coagulation Analyzer, Model CA-500
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 Sep 21, 1999 as substantially equivalent to K955278 (Behring Diagnostics, Inc., 1996) after a 35-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 21, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926551 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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…1 2517506 The Sysmex® CA-500 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer. 00016 510(k) Summary… | 1996 |
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- 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-500 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
e Prothrombin Time (PT)
e Activated Partial Thromboplastin Time (APTT)
¢ Fibrinogen (Clauss)
e Batroxobin
Protein C
" Thrombin Time
Extrinsic Factors (II, V, VII, X)
Intrinsic Factors (VIII, IX, XI, XII)
Chromogenic Analysis Parameters
e Antithrombin III e Heparin
+ Protein C
Calculated Parameters .
e PT Ratio e Derived Fibrinogen
e PTINR o 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/K992763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992763: Sysmex Automated Coagulation Analyzer, Model CA-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992763
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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