Cleared Traditional

K933092 - TAS ANALYZER

K933092 is an FDA 510(k) clearance for TAS ANALYZER, manufactured by Cardiovascular Diagnostic Services. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K933092 · Cardiovascular Diagnostic Services · Hematology device
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Nov 1993
Decision
144d
Days
Class 2
Risk

K933092 is an FDA 510(k) clearance for the TAS ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Cardiovascular Diagnostic Services (Durham, US). The FDA issued a Cleared decision on November 15, 1993 after a review of 144 days - within the typical 510(k) review window.

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: 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 Cardiovascular Diagnostic Services devices

FDA 510(k) Submission Details - K933092

510(k) Number K933092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1993
Decision Date November 15, 1993
Days to Decision 144 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
31d slower than avg
Panel avg: 113d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K933092.
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
K944227 · Medical Laboratory Automation Systems, Inc. · Feb 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
HEMOLAB
K931992 · Biomerieux Vitek, Inc. · Dec 1994
ELECTRA 1600C AUTOMATIC COAGULATION TIMER
K931206 · Medical Laboratory Automation Systems, Inc. · Aug 1993
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · Instrumentation Laboratory CO · Jun 1993