Cleared Traditional

K912069 - AVI MODEL 4225 VENTED PIGGYBACK IV ADMI...

K912069 is an FDA 510(k) clearance for AVI MODEL 4225 VENTED PIGGYBACK IV ADMI..., manufactured by 3M Avi, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 888-day FDA review.

K912069 · 3M Avi, Inc. · General Hospital
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Oct 1993
Decision
888d
Days
Class 2
Risk

K912069 is an FDA 510(k) clearance for the AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by 3M Avi, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 14, 1993 after a review of 888 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all 3M Avi, Inc. devices

FDA 510(k) Submission Details - K912069

510(k) Number K912069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date October 14, 1993
Days to Decision 888 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
759d slower than avg
Panel avg: 129d · This submission: 888d
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 575
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K912069.
HUBER NEEDLE INFUSION SET
K932638 · Douglas Medical Products Corp. · Dec 1993
INJECTION SITE
K932446 · 3M Health Care, Ltd. · Nov 1993
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
IVAC NEEDLELESS INJECTION VALVE
K922115 · Y · Oct 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
EXEL HUBER INFUSION SET ROTATING WING
K926119 · Exel Intl. · Aug 1993