Cleared Traditional

K812442 - 3M INFUSION SYSTEM

K812442 is the FDA 510(k) clearance for 3M INFUSION SYSTEM by 3M Company. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812442 · 3M Company · General Hospital
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Sep 1981
Decision
20d
Days
Class 2
Risk

K812442 is an FDA 510(k) clearance for the 3M INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 20 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.

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Submission Details

510(k) Number K812442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1981
Decision Date September 16, 1981
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K812442.
PORTABLE LIDOCAINE INFUSION PUMP
K812917 · Cardiac Pacemakers, Inc. · Nov 1981
IMED MODEL 970 & 975 VOL. INFUSION PUMP
K812823 · Imed Corp. · Oct 1981
PRESSURE DISC COMPONENT FOR ACCUSET
K812824 · Imed Corp. · Oct 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
VOLUMETRIC INFUSION PUMP
K812021 · American Edwards Laboratories · Jul 1981
IMED ACCUSET CASSETTE
K812035 · Imed Corp. · Jul 1981