Cleared Traditional

K896161 - AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.

K896161 is an FDA 510(k) clearance for AVI MODEL 2012, manufactured by 3M Company. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K896161

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.

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 1171
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K896161.
PORT INFUSION SET (PIS) INFUSION SET (IS)
K897065 · Prn Services, Inc. · Feb 1990
EXTENSION SET
K896561 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
K896346 · Pharmacia Deltec, Inc. · Jan 1990
CHEMO-SPIKE RECONSTITUTION DEVICE
K895290 · The Medi-Dose Group · Dec 1989
IV DISPESNSING SPIKE
K895291 · The Medi-Dose Group · Dec 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · Baxter Healthcare Corp · Dec 1989
K896161 · AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
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