Cleared Traditional

K944227 - ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER

K944227 is an FDA 510(k) clearance for ELECTRA 1400C AUTOMATIC COAGULATION ANA..., manufactured by Medical Laboratory Automation Systems, Inc.. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K944227 · Medical Laboratory Automation Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
155d
Days
Class 2
Risk

K944227 is an FDA 510(k) clearance for the ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 155 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 Medical Laboratory Automation Systems, Inc. devices

FDA 510(k) Submission Details - K944227

510(k) Number K944227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date February 03, 1995
Days to Decision 155 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
42d slower than avg
Panel avg: 113d · This submission: 155d
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 45
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K944227.
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
K954437 · Haemoscope Corp. · Jan 1996
PROTIME MICROCOAGULATION SYSTEM
K951072 · International Technidyne Corp. · Oct 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 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