Cleared Traditional

K902036 - STERI-VAC GAS STERILIZER MODEL 5XL

K902036 is an FDA 510(k) clearance for STERI-VAC GAS STERILIZER MODEL 5XL, manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K902036 · 3M Company · General Hospital
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Jul 1990
Decision
77d
Days
Class 2
Risk

K902036 is an FDA 510(k) clearance for the STERI-VAC GAS STERILIZER MODEL 5XL. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902036

510(k) Number K902036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1990
Decision Date July 19, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 25
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K902036.
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930 · Mdt Corp., Inc. · Mar 1993
MDT/CASTLE 10/90 LOAD STATION
K910649 · Mdt Biologic Co. · Sep 1991
JOSLYN EO STERILIZER/ EO MODERNIZATION KIT
K901146 · Joslyn Valve Corp. · Mar 1991
KARLSON OZONE STERILIZER MODEL 100B
K873200 · Life Enhancement Technologies, LLC · Jan 1989
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
K852115 · Ars Enterprises, Inc. · Nov 1985
ETHYLENE OXIDE GAS STERILIZA SYS II
K833457 · Ben Venue Laboratories, Inc. · Dec 1983
K902036 · STERI-VAC GAS STERILIZER MODEL 5XL
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