Cleared Abbreviated

K042760 - PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

K042760 is the FDA 510(k) clearance for PEFAKIT APC-R FACTOR V LEIDEN CONTROLS by Pentapharm , Ltd.. It is a Class 2 Hematology device (product code GGN) cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K042760 · Pentapharm , Ltd. · Hematology device
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Dec 2004
Decision
78d
Days
Class 2
Risk

K042760 is an FDA 510(k) clearance for the PEFAKIT APC-R FACTOR V LEIDEN CONTROLS. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Pentapharm , Ltd. (Washington, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 78 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pentapharm , Ltd. devices

Submission Details

510(k) Number K042760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date December 22, 2004
Days to Decision 78 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

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 K042760.
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