Cleared Traditional

K021902 - MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300

K021902 is an FDA 510(k) clearance for MAGELLAN AUTOLOGUS PLATELET SEPARATOR, manufactured by Medtronic Vascular. The device is a Class 1 Hematology device with product code JQC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K021902 · Medtronic Vascular · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
63d
Days
Class 1
Risk

K021902 is an FDA 510(k) clearance for the MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET S.... Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 12, 2002 after a review of 63 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.

FDA 510(k) Submission Details - K021902

510(k) Number K021902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2002
Decision Date August 12, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
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 37
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K021902.
SECQUIRE CELL SEPARATOR
K024080 · Perfusion Partners & Assoc., Inc. · Jul 2003
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
K030340 · Cytomedix · Apr 2003
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555 · Biomet, Inc. · Apr 2003
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148 · Implant Innovations, Inc. · Feb 2000
SMARTPREP CENTRIFUGE SYSTEM
K991430 · Harvest Technologies, LLC · May 1999
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
K944738 · Ducker CL · Oct 1994
K021902 · MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
Download PDF FDA Summary Medtronic Vascular