Cleared Traditional

K020147 - MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

K020147 is an FDA 510(k) clearance for MAGELLAN RATIO DISPENSER KIT/MAGELLAN S..., manufactured by Medtronic Perfusion Systems. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K020147 · Medtronic Perfusion Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
77d
Days
Class 2
Risk

K020147 is an FDA 510(k) clearance for the MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Brooklyn Park, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K020147

510(k) Number K020147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date April 03, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K020147.
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DUPLOREACH
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K014073 · Portex, Inc. · Feb 2002
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K012868 · Micromedics, Inc. · Oct 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc. · Sep 2001