Product IFU's
The 2 Active ONE TRAY® IFUs
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!.
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
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
270 degrees, 4 minutes, minimum 15-minute dry time, 365 event-related shelf life/storage
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
Condoc 753 Rev 00