Cleared Traditional

K070666 - GENESISCS COMPONENT CONCENTRATING SYSTEM

K070666 is the FDA 510(k) clearance for GENESISCS COMPONENT CONCENTRATING SYSTEM by Perfusion Partners & Assoc., Inc.. It is a Class 1 Hematology device (product code JQC) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K070666 · Perfusion Partners & Assoc., Inc. · Hematology device
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Jun 2007
Decision
100d
Days
Class 1
Risk

K070666 is an FDA 510(k) clearance for the GENESISCS COMPONENT CONCENTRATING SYSTEM. Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Perfusion Partners & Assoc., Inc. (Pahrump, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Perfusion Partners & Assoc., Inc. devices

Submission Details

510(k) Number K070666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date June 20, 2007
Days to Decision 100 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 113d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 15
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K070666.
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