Cleared Traditional

K904204 - THROMBELASTOGRAPH

K904204 is the FDA 510(k) clearance for THROMBELASTOGRAPH by Haemoscope Corp.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K904204 · Haemoscope Corp. · Hematology device
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Nov 1990
Decision
50d
Days
Class 2
Risk

K904204 is an FDA 510(k) clearance for the THROMBELASTOGRAPH. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Haemoscope Corp. (Morton Grove, US). The FDA issued a Cleared decision on November 1, 1990 after a review of 50 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 Haemoscope Corp. devices

Submission Details

510(k) Number K904204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date November 01, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
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 37
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K904204.
CASCADE 480
K921363 · Helena Laboratories · Jun 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · Helena Laboratories · Jan 1992
ST-4 COAGULATION INSTRUMENT
K904297 · American Bioproducts Co. · Nov 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380 · Helena Laboratories · May 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · Ortho Diagnostic Systems, Inc. · May 1990
KOAGULAB* 32-S COAGULATION SYSTEM
K885035 · Ortho Diagnostic Systems, Inc. · Feb 1989