Cleared Traditional

K964968 - MR EXTENSION SET (001)

K964968 is an FDA 510(k) clearance for MR EXTENSION SET (001), manufactured by University of Michigan. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K964968 · University of Michigan · General Hospital
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Feb 1997
Decision
77d
Days
Class 2
Risk

K964968 is an FDA 510(k) clearance for the MR EXTENSION SET (001). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by University of Michigan (Ann Arbor, US). The FDA issued a Cleared decision on February 27, 1997 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 880.5440 - 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 University of Michigan devices

FDA 510(k) Submission Details - K964968

510(k) Number K964968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date February 27, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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.

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 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964968.
NIPRO DISPOSABLE SOLUTION INFUSION SET
K970076 · Nipro Medical Corp. · Mar 1997
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
K964844 · Conmedcorp · Mar 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
K964876 · Vlv Associates, Inc. · Feb 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997
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