Cleared Traditional

K023290 - STERRAD 50 & STERRAD 100S STERILIZERS

K023290 is the FDA 510(k) clearance for STERRAD 50 & STERRAD 100S STERILIZERS by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FLF) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K023290 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
183d
Days
Class 2
Risk

K023290 is an FDA 510(k) clearance for the STERRAD 50 & STERRAD 100S STERILIZERS. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on April 3, 2003 after a review of 183 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 Advanced Sterilization Products devices

Submission Details

510(k) Number K023290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2002
Decision Date April 03, 2003
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - FLF Sterilizer, Ethylene-oxide Gas

All 8
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K023290.
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · Andersen Sterilizers, Inc. · Nov 2020
3M STERI-VAC STERILIZER/AERATOR
K142034 · 3M Company · Jan 2015
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
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · 3M Company · Jul 1990