Cleared Traditional

K172333 - Sysmex CS-5100

K172333 is an FDA 510(k) clearance for Sysmex CS-5100, manufactured by Siemens Healthcare Diagnostics Products GmbH. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172333 · Siemens Healthcare Diagnostics Products GmbH · Hematology device
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Oct 2017
Decision
90d
Days
Class 2
Risk

K172333 is an FDA 510(k) clearance for the Sysmex CS-5100. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on October 31, 2017 after a review of 90 days - within the typical 510(k) review window.

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 Siemens Healthcare Diagnostics Products GmbH devices

FDA 510(k) Submission Details - K172333

510(k) Number K172333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date October 31, 2017
Days to Decision 90 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
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

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 Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 165
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K172333.
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
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K173202 · Sekisui Medical Co., Ltd. · May 2018
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TEG 6s Hemostasis System
K160502 · Haemonetics Corporation · Apr 2017
ACL AcuStar
K170314 · Instrumentation Laboratory CO · Mar 2017
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K162688 · Siemens Healthcare Diagnostics Products GmbH · Dec 2016