Cleared Traditional

K964456 - POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367

K964456 is an FDA 510(k) clearance for POLYFIN QR WITH WINGS INFUSION SETS, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K964456 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
85d
Days
Class 2
Risk

K964456 is an FDA 510(k) clearance for the POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Minimed devices

FDA 510(k) Submission Details - K964456

510(k) Number K964456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date January 30, 1997
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964456.
VYGON BIONECTOR WITH EXTENSION SET
K963981 · Vygon Corp. · Feb 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
K964812 · Critical Device Corp. · Feb 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · Medtronic Minimed · Jan 1997
MODEL D-290P ADMINISTRATION SET
K964384 · Patient Solutions, Inc. · Jan 1997
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K960771 · Rymed Technologies, Inc. · Dec 1996
SAFECONNECT VALVE (CATALOG NO. XXXX)
K955775 · Faulding Medical Device Co. · Nov 1996