Cleared Traditional

K192978 - EOGas 4 Ethylene Oxide Gas Sterilizer

K192978 is an FDA 510(k) clearance for EOGas 4 Ethylene Oxide Gas Sterilizer, manufactured by Andersen Sterilizers, Inc.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K192978 · Andersen Sterilizers, Inc. · General Hospital
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Nov 2020
Decision
385d
Days
Class 2
Risk

K192978 is an FDA 510(k) clearance for the EOGas 4 Ethylene Oxide Gas Sterilizer. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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. Elevated predicate reliance profile. 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 Andersen Sterilizers, Inc. devices

FDA 510(k) Submission Details - K192978

510(k) Number K192978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2019
Decision Date November 12, 2020
Days to Decision 385 days
Submission Type Traditional
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
256d slower than avg
Panel avg: 129d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 9
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K192978.
3M STERI-VAC STERILIZER/AERATOR
K142034 · 3M Company · Jan 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
STERRAD 100 STERILIZATION SYSTEM
K915682 · Johnson & Johnson Medical, Inc. · Oct 1993
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930 · Mdt Corp., Inc. · Mar 1993