Are autoclaves regulated by the FDA?
Saniclave 102 FDA approved top load
Status:
Open Feb 02, 2026 - 12:37 PM
1answer
Answer
Feb 02, 2026 - 12:37 PM
Yes, autoclaves that are used for sterilizing medical devices are regulated by the FDA in the United States. They are classified as Class II medical devices, and manufacturers must comply with specific FDA requirements, including premarket notification (510(k)) and quality system regulations.
View More Product Details
Saniclave 102 FDA approved top load
" The FDA approved, Saniclave 102 is fashioned with a simple push button operation. The thermally protective polymer skin eliminates burn risk. Low water and under and over temperature alarms assure safety and effectiveness during operation. A corrosion resistant, stainless steel chamber makes ...
See More
View all Saniclave 102 FDA approved top load Questions & Answers
