Cleared Traditional

K954437 - THROMBELASTOGRAPH COAGULATION ANALYZER 3000S

K954437 is an FDA 510(k) clearance for THROMBELASTOGRAPH COAGULATION ANALYZER ..., manufactured by Haemoscope Corp.. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K954437 · Haemoscope Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
130d
Days
Class 2
Risk

K954437 is an FDA 510(k) clearance for the THROMBELASTOGRAPH COAGULATION ANALYZER 3000S. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Haemoscope Corp. (Skokie, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 130 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 Haemoscope Corp. devices

FDA 510(k) Submission Details - K954437

510(k) Number K954437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1995
Decision Date January 30, 1996
Days to Decision 130 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
17d slower than avg
Panel avg: 113d · This submission: 130d
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 K954437.
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
PROTIME MICROCOAGULATION SYSTEM
K951072 · International Technidyne Corp. · Oct 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
K944227 · Medical Laboratory Automation Systems, Inc. · Feb 1995