Sterilox Liquid Chemical Sterilant System
by Puricore, Inc. 510(k)
Active
510(k) K063159
Overview
The Sterilox Liquid Chemical Sterilant System is a high-level disinfectant apparatus designed for on-site electrochemical activation (electrolysis) of a dilute aqueous sodium chloride (NaCl) solution. It generates a single-use disinfectant solution for cleaning reusable, heat-sensitive medical devices and instruments, ensuring microbial decontamination without heat sterilization.
The system is intended for use in general hospital settings and operates by circulating the activated disinfectant solution over internal and external surfaces of reusable medical devices. Supplied as a reusable device, it requires proper storage and handling to maintain efficacy. The Sterilox Liquid Chemical Sterilant System holds an FDA 510(k) clearance (K063159) under the Medical Device classification (MED), with regulatory compliance under 21 CFR 880.6885.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063159 | Date2 Apr 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MED
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6885
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puricore, Inc.
Questions
What is the Sterilox Liquid Chemical Sterilant System used for?
The Sterilox Liquid Chemical Sterilant System is designed for on-site electrochemical activation of a dilute sodium chloride (NaCl) solution. It produces a single-use disinfectant solution specifically for cleaning reusable, heat-sensitive medical devices and instruments in general hospital settings. The system ensures microbial decontamination without the need for heat sterilization, making it suitable for items that cannot withstand high-temperature processing.
How is the Sterilox Liquid Chemical Sterilant System supplied and what is its sterility status?
The Sterilox Liquid Chemical Sterilant System is supplied as a reusable device. It does not generate a sterile solution itself but produces a single-use disinfectant solution from a dilute aqueous sodium chloride solution. The system requires proper handling and storage to maintain its efficacy, but the generated disinfectant solution is intended for high-level disinfection rather than sterilization. Users must follow manufacturer guidelines for preparing and using the solution to ensure proper microbial decontamination.
Is the Sterilox Liquid Chemical Sterilant System intended for single-use or reuse?
The Sterilox Liquid Chemical Sterilant System itself is a reusable device. However, the disinfectant solution it generates is designed for single-use only. Each batch of activated solution is intended to be used once for cleaning reusable medical devices, ensuring microbial decontamination without the need for repeated use of the same solution.
What regulatory approval does the Sterilox Liquid Chemical Sterilant System hold?
The Sterilox Liquid Chemical Sterilant System holds an FDA 510(k) clearance under the classification of Medical Devices (MED), specifically under 21 CFR 880.6885. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and is intended for use in general hospital settings for high-level disinfection of reusable, heat-sensitive medical devices.
How does the Sterilox Liquid Chemical Sterilant System differ from traditional heat sterilization methods?
Unlike traditional heat sterilization methods, the Sterilox Liquid Chemical Sterilant System uses electrochemical activation to generate a disinfectant solution from a dilute sodium chloride solution. This process allows for high-level disinfection of reusable medical devices that are heat-sensitive, meaning they cannot withstand the high temperatures required for steam or chemical vapor sterilization. The system circulates the activated solution over the surfaces of the devices, ensuring microbial decontamination without exposing them to heat.