Cleared Traditional

K896161 - AVI MODEL 2012

K896161 is the FDA 510(k) clearance for AVI MODEL 2012 by 3M Company. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K896161 · 3M Company · General Hospital
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Jan 1990
Decision
79d
Days
Class 2
Risk

K896161 is an FDA 510(k) clearance for the AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 79 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 K896161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date January 11, 1990
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K896161.
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K895046 · Pharmacia Deltec, Inc. · Oct 1989
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