Cleared Traditional

K992423 - SYSMEX AUTOMATED COAGULATION ANALYZER

K992423 is the FDA 510(k) clearance for SYSMEX AUTOMATED COAGULATION ANALYZER by Dade Behring, Inc.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K992423 · Dade Behring, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
62d
Days
Class 2
Risk

K992423 is an FDA 510(k) clearance for the SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Miami, US). The FDA issued a Cleared decision on September 21, 1999 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K992423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1999
Decision Date September 21, 1999
Days to Decision 62 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
51d faster than avg
Panel avg: 113d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - GKP Instrument, Coagulation, Automated

All 33
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K992423.
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · Dade Behring, Inc. · May 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · Dade Behring, Inc. · Dec 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · Dade Behring, Inc. · Nov 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · Dade Behring, Inc. · Sep 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · Dade Behring, Inc. · Sep 1999
COAG-A-MATE MAX
K991101 · Organon Teknika Corp. · Jun 1999