Cleared Traditional

K013280 - STERILOX LIQUID CHEMICAL STERILANT SYSTEM

K013280 is an FDA 510(k) clearance for STERILOX LIQUID CHEMICAL STERILANT SYSTEM, manufactured by Sterilox Technologies, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K013280 · Sterilox Technologies, Inc. · General Hospital
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Sep 2002
Decision
351d
Days
Class 2
Risk

K013280 is an FDA 510(k) clearance for the STERILOX LIQUID CHEMICAL STERILANT SYSTEM. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Sterilox Technologies, Inc. (Yardley, US). The FDA issued a Cleared decision on September 18, 2002 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Sterilox Technologies, Inc. devices

FDA 510(k) Submission Details - K013280

510(k) Number K013280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date September 18, 2002
Days to Decision 351 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 129d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 43
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K013280.
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