Cleared Traditional

K173202 - CP3000 Coagulation analyzer

K173202 is the FDA 510(k) clearance for CP3000 Coagulation analyzer by Sekisui Medical Co., Ltd.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K173202 · Sekisui Medical Co., Ltd. · Hematology device
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May 2018
Decision
219d
Days
Class 2
Risk

K173202 is an FDA 510(k) clearance for the CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia .... Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sekisui Medical Co., Ltd. (Chuo-Ku, JP). The FDA issued a Cleared decision on May 9, 2018 after a review of 219 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sekisui Medical Co., Ltd. devices

Submission Details

510(k) Number K173202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date May 09, 2018
Days to Decision 219 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 113d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Consultant

SEKISUI Diagnostics, LLC
Shelly Harris

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 95
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