Cleared Traditional

K891009 - INTRAVASCULAR ADMINISTRATION SET MODEL ...

K891009 is the FDA 510(k) clearance for INTRAVASCULAR ADMINISTRATION SET MODEL ... by 3M Company. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K891009 · 3M Company · General Hospital
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May 1989
Decision
77d
Days
Class 2
Risk

K891009 is an FDA 510(k) clearance for the INTRAVASCULAR ADMINISTRATION SET MODEL 60040. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 16, 1989 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 3M Company devices

Submission Details

510(k) Number K891009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date May 16, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
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.

Device Classification

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

All 20
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K891009.
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987