Cleared Traditional

AVI MODEL 400D INFUSION PUMP (K912590) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912590 · 3M Avi, Inc. · General Hospital
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Oct 1991
Decision
129d
Days
Class 2
Risk

K912590 is an FDA 510(k) clearance for the AVI MODEL 400D 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 October 17, 1991 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Avi, Inc. devices

Submission Details

510(k) Number K912590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date October 17, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K912590.
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · Baxter Healthcare Corp · Oct 1991
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · Abbott Laboratories · Aug 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · Abbott Laboratories · Aug 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · Abbott Laboratories · Aug 1991