Cleared Traditional

COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984129 · Pacific Hemostasis · Hematology device
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Dec 1998
Decision
13d
Days
Class 2
Risk

K984129 is an FDA 510(k) clearance for the COAGULATION CONTROL LEVEL 1 (NORMAL). Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on December 1, 1998 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Pacific Hemostasis devices

Submission Details

510(k) Number K984129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date December 01, 1998
Days to Decision 13 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
100d faster than avg
Panel avg: 113d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIZ Plasma, Control, Normal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.