Cleared Traditional

K792050 - 3M SMALL VOLUME INFUSTION (SVI) SYSTEM

K792050 is the FDA 510(k) clearance for 3M SMALL VOLUME INFUSTION (SVI) SYSTEM by 3M Company. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K792050 · 3M Company · General Hospital
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Mar 1980
Decision
150d
Days
Class 2
Risk

K792050 is an FDA 510(k) clearance for the 3M SMALL VOLUME INFUSTION (SVI) 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 March 10, 1980 after a review of 150 days - an extended review 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: 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.

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Submission Details

510(k) Number K792050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1979
Decision Date March 10, 1980
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 K792050.
AMBULATORY INFUSION PUMP, CODE 2M9807
K800627 · Travenol Laboratories, S.A. · Jul 1980
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · Travenol Laboratories, S.A. · May 1980
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
MODEL IV 6500 FORMULATOR
K792142 · Valleylab, Inc. · Nov 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · Abbott Laboratories · Sep 1979
ALARM
K790559 · Maddak, Inc. · Jun 1979