510(k) · Cleared
ClearedCP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sekisui Medical Co., Ltd. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on May 9, 2018 as substantially equivalent to K160276 (Instrumentation Laboratory CO, 2016) and 4 other predicates after a 219-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- May 9, 2018
- Review
- 219 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K002400 (2000). 19 ancestors in all, the oldest K864271 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 5 generations backK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004 · Recalled
- 4 generations backK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- 3 generations backK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- 2 generations backK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- 1 generation backK160276 Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500…Instrumentation Laboratory CO · 2016 · Recalled
- This deviceK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −5 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| −4 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| −3 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| −2 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| −1 | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl… | Instrumentation Laboratory CO | 2016 | 1 |
| 0 (this device) | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
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? (5)
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 |
|---|---|---|---|
| * | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)Summary page 5…E DEVICES [807.92(A)(3)] Trade Name Predicate Device Predicate 510(k) Number CP3000 ACL TOP K160276- ACL TOP 700 LAS Coagpia AT Reagent HemosIL Liquid Antithrombin K062431 Coagpia Calibrator HemosI… | 2016 |
| * | K062431 | Hemosil Liquid AntithrombinSummary page 5…P3000 ACL TOP K160276- ACL TOP 700 LAS Coagpia AT Reagent HemosIL Liquid Antithrombin K062431 Coagpia Calibrator HemosIL Calibration Plasma K041905 Coagpia Control Set HemosIL Normal Control… | 2006 |
| * | K041905 | Hemosil Calibration PlasmaSummary page 5…ACL TOP 700 LAS Coagpia AT Reagent HemosIL Liquid Antithrombin K062431 Coagpia Calibrator HemosIL Calibration Plasma K041905 Coagpia Control Set HemosIL Normal Control Assayed K021023 HemosIL Low Abnormal Co… | 2004 |
| * | K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)Summary page 5…K062431 Coagpia Calibrator HemosIL Calibration Plasma K041905 Coagpia Control Set HemosIL Normal Control Assayed K021023 HemosIL Low Abnormal Control Assayed K021024 5.4. DEVICE DESCRIPTION [807.92 (A)(4)] Trad… | 2002 |
| * | K021024 | Hemosil High Abnormal Control AssayedSummary page 5…K041905 Coagpia Control Set HemosIL Normal Control Assayed K021023 HemosIL Low Abnormal Control Assayed K021024 5.4. DEVICE DESCRIPTION [807.92 (A)(4)] Trade Name Device Description CP3000 The CP3000 is designed for e… | 2002 |
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 18 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K160276.
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. 2018, 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?
CP3000 analyzer The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays. Coagpia AT Reagent Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use…
Read the full statement (161 words)
CP3000 analyzer
The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays.
Coagpia AT Reagent
Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.
Coagpia Calibrator
The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.
- Coagpia AT Reagent
Coagpia Control Set
The Coagpia Control Set contains 2 levels of assayed plasma intended for the quality control of the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use.
- Coagpia AT Reagent
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173202
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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