Cleared Traditional

K990046 - PACIFIC HEMOSTASIS IMMUNODEPLETED FACTO...

K990046 is the FDA 510(k) clearance for PACIFIC HEMOSTASIS IMMUNODEPLETED FACTO... by Pacific Hemostasis. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K990046 · Pacific Hemostasis · Hematology device
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Feb 1999
Decision
41d
Days
Class 2
Risk

K990046 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on February 17, 1999 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K990046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1999
Decision Date February 17, 1999
Days to Decision 41 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
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 61
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K990046.
HEMOSIL FACTOR XI DEFICIENT PLASMA
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K024082 · Instrumentation Laboratory CO · Feb 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · Instrumentation Laboratory CO · Jan 2003
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · Dade Behring, Inc. · Oct 1998
STA - LIATEST VWF TEST KIT
K962675 · American Bioproducts Co. · Oct 1996
STA-VWF CALIBRATOR KIT
K962671 · American Bioproducts Co. · Sep 1996