Sterizone VP4 Sterilizer
by Ts03, Inc. 510(k)
Active
510(k) K153392
Overview
The Sterizone VP4 Sterilizer is a Two or More Sterilant Sterilizer (FDA Product Code PJJ) designed for terminal sterilization of reusable medical devices using low-temperature methods. It employs multiple sterilants to effectively eliminate microbial contaminants from both metal and non-metal instruments, including complex devices such as multi-channel flexible endoscopes within specified dimensional limits.
This device is intended for use in healthcare facilities such as general hospitals, central sterile supply departments (CSSDs), operating rooms, outpatient surgery centers, laboratories, and biomedical research settings. Supplied as a reusable medical instrument, it requires adherence to manufacturer guidelines for cleaning, rinsing, drying, and sterilization cycles. The Sterizone VP4 Sterilizer holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under regulation number 880.6860.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153392 | Date24 Mar 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PJJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of medical devices can the Sterizone VP4 Sterilizer process, and what are the key limitations regarding their size or complexity?
The Sterizone VP4 Sterilizer is designed for terminal sterilization of reusable medical devices using low-temperature methods, including both metal and non-metal instruments. It is specifically capable of processing complex devices like multi-channel flexible endoscopes, but only those within specified dimensional limits. The device employs multiple sterilants to ensure effective microbial elimination, so compatibility with the sterilant system is a critical factor in determining suitability for a given device.
How is the Sterizone VP4 Sterilizer supplied, and what maintenance steps are required before each use?
The Sterizone VP4 Sterilizer is supplied as a reusable medical instrument, meaning it is not single-use. Before each sterilization cycle, it requires adherence to manufacturer guidelines for cleaning, rinsing, and drying to ensure proper functionality and sterilization efficacy. These steps are essential to prevent cross-contamination and maintain the device’s performance.
In what healthcare settings is the Sterizone VP4 Sterilizer intended to be used, and why?
The Sterizone VP4 Sterilizer is intended for use in healthcare facilities such as general hospitals, central sterile supply departments (CSSDs), operating rooms, outpatient surgery centers, laboratories, and biomedical research settings. Its design supports low-temperature sterilization, which is particularly useful in environments where heat-sensitive devices—such as endoscopes or delicate instruments—must be processed without risking damage from high-temperature sterilization methods.
What regulatory pathway was followed for FDA clearance of the Sterizone VP4 Sterilizer, and what does this classification mean for its use?
The Sterizone VP4 Sterilizer received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II device under regulation number 880.6860. This classification indicates that the device is subject to general controls and special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance requirements. The clearance was granted based on a determination of substantial equivalence to a predicate device, ensuring it meets established regulatory standards.