Cleared Abbreviated

K042473 - COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (FDA 510(k) Clearance)

Class I Hematology device.

K042473 · Cobe Cardiovascular, Inc. · Hematology device
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Nov 2004
Decision
67d
Days
Class 1
Risk

K042473 is an FDA 510(k) clearance for the COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM. Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on November 19, 2004 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - 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 Cobe Cardiovascular, Inc. devices

Submission Details

510(k) Number K042473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date November 19, 2004
Days to Decision 67 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
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.