Cleared Traditional

K942097 - TOA MEDICAL ELECTRONICS CA-5000

K942097 is the FDA 510(k) clearance for TOA MEDICAL ELECTRONICS CA-5000 by Sysmex Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K942097 · Sysmex Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
344d
Days
Class 2
Risk

K942097 is an FDA 510(k) clearance for the TOA MEDICAL ELECTRONICS CA-5000. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sysmex Corp. (Los Alamitos, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sysmex Corp. devices

Submission Details

510(k) Number K942097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date March 24, 1995
Days to Decision 344 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
231d slower than avg
Panel avg: 113d · This submission: 344d
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 Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K942097.
ACL FUTURA COAGULATION SYSTEM
K951891 · Instrumentation Laboratory CO · Nov 1995
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · International Technidyne Corp. · Oct 1994
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994
JR. MICROCOAGULATION SYSTEM
K940401 · International Technidyne Corp. · May 1994