Cleared Traditional

K070666 - GENESISCS COMPONENT CONCENTRATING SYSTEM

K070666 is an FDA 510(k) clearance for GENESISCS COMPONENT CONCENTRATING SYSTEM, manufactured by Perfusion Partners & Assoc., Inc.. The device is a Class 1 Hematology device with 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

FDA 510(k) Submission Details - K070666

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 113d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

JQC Device Classification - Class 1, General Controls

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 21
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K070666.
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
K183205 · Emcyte Corporation · May 2019
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340 · Harvest Technologies, Corp. · Dec 2010
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934 · Biomet Manufacturing Corp · Oct 2007
SMARTPREP2 CENTRIFUGE SYSTEM
K052925 · Harvest Technologies, Corp. · Jan 2006
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K042473 · Cobe Cardiovascular, Inc. · Nov 2004
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555 · Biomet, Inc. · Apr 2003