# K252854: SteriTite Container System with MediTray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Jun 3, 2026 after 268 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: 5 generations back to K871202 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240898: SteriTite rigid reusable sterilization container with MediTray Products, Case Medical (2024) Summary page 9.

## Indications for use
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed devices until it is used. The perforated bottom container configuration is compatible for use with the following steam sterilization cycles: Steam Cycle with Steam Flush Pressure Pulses (SFPP): -At 132°C for 4 minutes with a 30-minute dry time -At 135°C for 3 minutes with a 30-minute dry time Note: The validation studies were performed using a 4 SFPP cycle with a validation load consisting of unwrapped metal items with a total weight of 25 lbs. (including the SteriTite container). In addition, the SteriTite container, also available with a solid bottom, is compatible with low-temperature sterilizers, and is compatible with the following sterilizers and cycles identified below: - SteriTite solid bottom Container: STERRAD 100NX - Express Cycle (surface sterilization of medical devices only; no lumens). Note: The validation studies were performed using a validation load consisting of a da Vinci X/Xi 8mm Endoscope with a total weight of 22.4 lbs. (including the SteriTite container). - SteriTite solid bottom Container: STERRAD 100NX - DUO Cycle (surface sterilization of medical devices only; no lumens). Note: The validation studies were performed using a validation load consisting of non-lumened devices with a total weight of 13.2 lbs. (including the SteriTite container). Refer to the specific Sterilizer user manual for information regarding the processing of appropriate devices and device types. See labeling for tables of compatible devices and maximum load weight recommendations including the weight of the sterilization container.

Source page: https://510kreport.com/device/K252854
Methodology: https://510kreport.com/methodology