Cleared Abbreviated

K142034 - 3M STERI-VAC STERILIZER/AERATOR

K142034 is an FDA 510(k) clearance for 3M STERI-VAC STERILIZER/AERATOR, manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FLF cleared through the Abbreviated 510(k) pathway after a 164-day FDA review.

K142034 · 3M Company · General Hospital
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Jan 2015
Decision
164d
Days
Class 2
Risk

K142034 is an FDA 510(k) clearance for the 3M STERI-VAC STERILIZER/AERATOR. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all 3M Company devices

FDA 510(k) Submission Details - K142034

510(k) Number K142034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date January 08, 2015
Days to Decision 164 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Standards-based clearance path.

FLF Device Classification - Class 2, Special Controls

Product Code FLF Sterilizer, Ethylene-oxide Gas
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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 - FLF Sterilizer, Ethylene-oxide Gas

All 13
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K142034.
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · Andersen Sterilizers, Inc. · Nov 2020
Anprolene AN75 Ethylene Oxide Gas Sterilizer
K170432 · Andersen Sterilizers, Inc. · Oct 2017
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646 · Andersen Sterilizers, Inc. · Nov 2015
STERRAD 50 & STERRAD 100S STERILIZERS
K023290 · Advanced Sterilization Products · Apr 2003
STERI-VAC GAS STERILIZER MODEL 8XL
K941748 · 3M Health Care, Ltd. · Dec 1994
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · American Sterilizer Co. · Feb 1994