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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Citech

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MED Sterilant, Medical Devices

All 63
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K013280.
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K033381 · Discus Dental, Inc. · Jan 2004
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · Pascal Co., Inc. · May 2003
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · Advanced Sterilization Products · Feb 2003
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
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CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · Medivators, Inc. · Aug 2000

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K013280 · STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Download PDF FDA Summary Sterilox Technologies…