Cleared Abbreviated

K142034 - 3M STERI-VAC STERILIZER/AERATOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K142034 · 3M Company · General Hospital
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Optimized for regulatory review, auditing and printing
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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 128d · This submission: 164d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.