Cleared Traditional

K941748 - STERI-VAC GAS STERILIZER MODEL 8XL

K941748 is an FDA 510(k) clearance for STERI-VAC GAS STERILIZER MODEL 8XL, manufactured by 3M Health Care, Ltd.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K941748 · 3M Health Care, Ltd. · General Hospital
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Dec 1994
Decision
238d
Days
Class 2
Risk

K941748 is an FDA 510(k) clearance for the STERI-VAC GAS STERILIZER MODEL 8XL. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 238 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 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 3M Health Care, Ltd. devices

FDA 510(k) Submission Details - K941748

510(k) Number K941748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1994
Decision Date December 02, 1994
Days to Decision 238 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
109d slower than avg
Panel avg: 129d · This submission: 238d
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 15
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K941748.
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K023290 · Advanced Sterilization Products · Apr 2003
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