Cleared Traditional

K961474 - POLYFIN INFUSION SET MMT-106/MMT-107/MM...

K961474 is the FDA 510(k) clearance for POLYFIN INFUSION SET MMT-106/MMT-107/MM... by Medtronic Minimed. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K961474 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
18d
Days
Class 2
Risk

K961474 is an FDA 510(k) clearance for the POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133. 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 May 6, 1996 after a review of 18 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

Submission Details

510(k) Number K961474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date May 06, 1996
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K961474.
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996
V2 INJECTION SITE
K955585 · B.Braun Medical, Inc. · May 1996
SNAPDOSE DEVICE
K955410 · Abbott Laboratories · May 1996
IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
K960280 · Y · Apr 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825 · AngioDynamics, Inc. · Feb 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969 · Medtronic Minimed · Feb 1996