The ONE TRAY sterilization container from Innovative Sterilization Technologies (IST) has received a second clearance from the U.S. Food and Drug Administration (FDA), significantly expanding its use across hospital and surgical facility workflows. ONE TRAY’s original clearance in 2006 (IFU K052567) included sterilization at 270°F (132°C), exposure time 4 minutes, cycle dry time not required and validated to maintain the sterility of the contents for up to a 48-hour storage period. ONE TRAY’s additional clearance in 2025 (IFU K250029) maintains the same validated sterilization parameters – 270°F (132°C), exposure time 4 minutes, but with a 365-day event related shelf life/storage period with a 15-minute minimum dry time.
When introduced in 2006, ONE TRAY represented a new approach to sealed sterilization container technology. Now, according to Barbara Ann Harmer MHA, BSN, RN, vice president of clinical services at IST, the expanded storage window provides facilities with even more operational flexibility.
