Cleared Traditional

K940446 - 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)

K940446 is an FDA 510(k) clearance for 3M MODEL 3000 & MODEL 3100 INFUSION PUM..., manufactured by Minnesota Mining and Mfg. Co.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K940446 · Minnesota Mining and Mfg. Co. · General Hospital
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Aug 1994
Decision
195d
Days
Class 2
Risk

K940446 is an FDA 510(k) clearance for the 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Minnesota Mining and Mfg. Co. (St. Paul, US). The FDA issued a Cleared decision on August 15, 1994 after a review of 195 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.

View all Minnesota Mining and Mfg. Co. devices

FDA 510(k) Submission Details - K940446

510(k) Number K940446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 01, 1994
Decision Date August 15, 1994
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K940446.
SMART DOSE(TM)
K943692 · River Medical, Inc. · Apr 1995
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
LOCKBOX
K942161 · Pharmacia Deltec, Inc. · Aug 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
CORPAK ENTERAL PUMP
K932847 · Corpak Co. · Jun 1994