Cleared Traditional

K173202 - CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173202 · Sekisui Medical Co., Ltd. · Hematology device
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Optimized for regulatory review, auditing and printing
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
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.

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