Cleared Traditional

K951072 - PROTIME MICROCOAGULATION SYSTEM

K951072 is an FDA 510(k) clearance for PROTIME MICROCOAGULATION SYSTEM, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K951072 · International Technidyne Corp. · Hematology device
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Oct 1995
Decision
233d
Days
Class 2
Risk

K951072 is an FDA 510(k) clearance for the PROTIME MICROCOAGULATION SYSTEM. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 233 days - an extended review 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: 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K951072

510(k) Number K951072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1995
Decision Date October 27, 1995
Days to Decision 233 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 113d · This submission: 233d
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 43
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K951072.
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K962664 · Medical Laboratory Automation Systems, Inc. · Sep 1996
ACL 6000 SYSTEM (ACL 6000)
K961991 · Instrumentation Laboratory CO · Sep 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
K944227 · Medical Laboratory Automation Systems, Inc. · Feb 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995