The ONE TRAY IFU's

ONE TRAY® now has a NEW additional FDA 510(k) clearance with 365 day event-related storage with a 15 minute minimum dry time, expanding how facilities can align sterilization workflows with real-world OR demands. With two FDA 510(k) clearances, ONE TRAY® provides validated options to support consistent and standardized sterilization and storage practices (when used in accordance to the IFU) so facilities can JUST ONE TRAY® IT!.

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      2006 FDA Clearance K052567

  • Exposure Temperature: 270°F (132°C)
  • Exposure Time: 4 Minutes
  • Dry Time: Not Required
  • Cool Time: Varies according to load
  • Validated Storage Period: 48 hrs

       Download This IFU

    2025 FDA Clearance K250029

  • Exposure Temperature: 270°F (132°C)
  • Exposure Time: 4 Minutes
  • Dry Time: 15 Minute Minimum
  • Cool Time: Varies according to load
  • Event Related Shelf Life/Storage Period: 365 Days

     Download This IFU

Both clearances utilize the same sterilization parameters of 270°F (132°C) for a 4-minute exposure, allowing teams to standardize processes while adapting to day-of-surgery demands or longer-term storage requirements. This flexibility helps SPD and OR teams optimize turnaround, manage instrument availability, and align sterilization practices with real-world operational pressures without changing container systems.

Together, the dual clearances allow facilities to support efficiency, consistency, and workflow confidence across the full chain of custody..

Want to talk more about this new IFU?

Reach out to Barbara Ann Harmer, MHA, BSN, RN HERE!

Follow one of the following IFUs for use: K052567 and K250029.

Reference 510k summary- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052567 

Reference 510k summary- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250029

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