Cleared Traditional

K992279 - HEPARIN CONTROL PLASMA LEVEL 2

K992279 is the FDA 510(k) clearance for HEPARIN CONTROL PLASMA LEVEL 2 by Pacific Hemostasis. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K992279 · Pacific Hemostasis · Hematology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
50d
Days
Class 2
Risk

K992279 is an FDA 510(k) clearance for the HEPARIN CONTROL PLASMA LEVEL 2. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on August 26, 1999 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 K992279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1999
Decision Date August 26, 1999
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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.

Regulatory Peers - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K992279.
HEMOSIL NORMAL CONTROL (ASSAYED)
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CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
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K990858 · Bio-Rad · Apr 1999
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K981248 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · Sigma Diagnostics, Inc. · Apr 1998