Cleared Traditional

K903782 - AVI MODEL 270CM INFUSION PUMP

K903782 is an FDA 510(k) clearance for AVI MODEL 270CM 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 16-day FDA review.

K903782 · 3M Avi, Inc. · General Hospital
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Sep 1990
Decision
16d
Days
Class 2
Risk

K903782 is an FDA 510(k) clearance for the AVI MODEL 270CM 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 September 5, 1990 after a review of 16 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 - K903782

510(k) Number K903782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date September 05, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 491
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K903782.
MULTI-DRUG INFUSION SYSTEM
K901978 · I-Flow Corp. · Sep 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K902374 · Pharmacia Deltec, Inc. · Sep 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