# K222328: SteriCUBE® Multiple Tray Sterilization Systems

- Pathway: 510(k) (Traditional)
- Applicant: Stericube, LLC
- Decided: Sep 28, 2022 after 57 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K110898 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190541: MTS225 and MTS300 Multiple Tray Sterilization Systems, Pmbs, LLC (2019) Summary page 4.

## Indications for use
The SteriCUBE Multiple Tray Sterilization System (SteriCUBE System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks. The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 Ibs. per tray. The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm. Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.

Source page: https://510kreport.com/device/K222328
Methodology: https://510kreport.com/methodology