Pre-Vacuum Tabletop Autoclave
by Tuttnauer U.S.A Co, Ltd. 510(k)
Active
510(k) K143311
Overview
This device is a Steam Sterilizer (Class II, FDA 510(k) K143311) designed for pre-vacuum sterilization of medical and surgical instruments, devices, and supplies. It employs a pre-vacuum cycle to remove air from the chamber before steam exposure, ensuring effective sterilization of wrapped, unwrapped, solid, hollow, and porous items by achieving high-temperature steam penetration and elimination of microbial contaminants.
The Pre-Vacuum Tabletop Autoclave is intended for use in general hospital settings and operates as a stand-alone, tabletop unit. It is single-use or reusable (as per manufacturer specifications) and requires compliance with FDA 510(k) clearance (Traditional pathway, Substantially Equivalent). The device is not MRI-safe and must be stored in a dry, well-ventilated area per manufacturer guidelines. No explicit sterility claims are provided in the data, but standard autoclave sterilization protocols apply.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143311 | Date15 Jan 2015 | 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- Withdrawn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
- FLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tuttnauer USA Co. Ltd.
Questions
What types of items can the Pre-vacuum Tabletop Autoclave sterilize, and how does its pre-vacuum cycle benefit them?
The Pre-vacuum Tabletop Autoclave is designed to sterilize a wide range of medical and surgical items, including wrapped, unwrapped, solid, hollow, and porous materials. The pre-vacuum cycle removes air from the chamber before steam exposure, ensuring deep steam penetration and effective elimination of microbial contaminants—critical for items like instruments, devices, and supplies where thorough sterilization is essential.
Is this autoclave intended for use in specific clinical settings, and how does its design accommodate those environments?
Yes, the device is specifically intended for use in general hospital settings. It operates as a standalone, tabletop unit, making it suitable for spaces with limited floor space or where integration into existing workflows is necessary. Its compact design allows for easy placement near sterilization stations or procedure areas.
How should the Pre-vacuum Tabletop Autoclave be stored, and are there any environmental requirements to maintain its performance?
The device must be stored in a dry, well-ventilated area, as specified by the manufacturer. Proper ventilation prevents moisture buildup or corrosion, which could affect its performance or longevity. Avoid storing it in damp or enclosed spaces to ensure reliable operation.
What does the manufacturer’s note about single-use or reusable status mean for maintenance and operational workflows?
The manufacturer specifies that the device can be used either as a single-use or reusable unit, depending on the intended application and facility protocols. If reused, it must follow the manufacturer’s guidelines for cleaning, maintenance, and sterilization between cycles to ensure safety and efficacy. This flexibility allows facilities to tailor usage based on their specific needs and infection control policies.
What regulatory pathway was followed for FDA clearance, and what does ‘Substantially Equivalent’ mean in this context?
The Pre-vacuum Tabletop Autoclave received FDA clearance through the Traditional 510(k) pathway, determined to be ‘Substantially Equivalent’ (SESE) to a legally marketed predicate device. This means the FDA found that the new device has the same intended use and technological characteristics as the predicate, ensuring it meets safety and effectiveness standards without requiring a full de novo review.