Cleared Traditional

K903784 - AVI MODEL 480CM INFUSION PUMP

K903784 is an FDA 510(k) clearance for AVI MODEL 480CM INFUSION PUMP, manufactured by 3M Avi, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K903784 · 3M Avi, Inc. · General Hospital
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Aug 1990
Decision
10d
Days
Class 2
Risk

K903784 is an FDA 510(k) clearance for the AVI MODEL 480CM INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by 3M Avi, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Avi, Inc. devices

FDA 510(k) Submission Details - K903784

510(k) Number K903784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date August 30, 1990
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 498
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K903784.
AVI MODEL 470CM INFUSION PUMP
K903787 · 3M Avi, Inc. · Sep 1990
AVI MICRO 285CM INFUSION PUMP
K903788 · 3M Avi, Inc. · Sep 1990
AVI MODEL 880 DUAL CHANNEL INFUSION PUMP
K903781 · 3M Avi, Inc. · Aug 1990
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K896075 · Pharmacia Deltec, Inc. · Aug 1990