# K240898: SteriTite rigid reusable sterilization container with MediTray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical
- Decided: Jul 31, 2024 after 121 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: 4 generations back to K871202 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212711: SteriTite Container System with MediTray Products, Case Medical, Inc. (2022) Summary page 6.

## Most influential descendants
- K252854: SteriTite Container System with MediTray Products (2026), 0 descendants of its own

## 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 device until it is used. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container) - STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)

Source page: https://510kreport.com/device/K240898
Methodology: https://510kreport.com/methodology