Cleared Traditional

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340) - FDA 510(k) Clearance

Class I Hematology device.

K030340 · Cytomedix · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
70d
Days
Class 1
Risk

K030340 is an FDA 510(k) clearance for the AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129). Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Cytomedix (Walker, US). The FDA issued a Cleared decision on April 11, 2003 after a review of 70 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 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 Cytomedix devices

Submission Details

510(k) Number K030340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2003
Decision Date April 11, 2003
Days to Decision 70 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
43d faster than avg
Panel avg: 113d · This submission: 70d
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 37
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K030340.
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
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555 · Biomet, Inc. · Apr 2003
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
K021902 · Medtronic Vascular · Aug 2002
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
K860747 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1986
ROTOR SYSTEMS A/S-400 & LA/S-400
K850485 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
UNIVERSAL 2 S CENTRIFUGE
K843087 · Boehringer Mannheim Corp. · Aug 1984