510(k) K250029

ONE TRAY® Sealed Sterilization Container System by Innovative Sterilization Technologies — Product Code KCT

K250029 is an FDA 510(k) premarket notification submitted by Innovative Sterilization Technologies for the device "ONE TRAY® Sealed Sterilization Container System". The FDA issued a decision of Substantially Equivalent on May 1, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850.