# K212711: SteriTite Container System with MediTray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Apr 29, 2022 after 246 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 K871202 (1987). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173259: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories, Case Medical, Inc. (2018) Summary page 12.

## Most influential descendants
- K240898: SteriTite rigid reusable sterilization container with MediTray Products (2024), 1 descendant of its own
- K252854: SteriTite Container System with MediTray Products (2026), 0 descendants of its own
- K221492: SteriTite Container System with MediTray Parts (2022), 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. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60 (Flexible and Lumen cycle) - STERIS V-Pro s2 (Flexible and Lumen cycle) - STERIS V-Pro maX 2 (Lumen and Flexible cycle) - STERIS V-Pro maX (Lumen and Flexible cycle) - STERRAD 100NX (ALLCLEAR-DUO cycle) - Sterizone VP4 (Cycle 1) Refer to the specific Sterilizer user manual and vendor provided information regarding the processing of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.

Source page: https://510kreport.com/device/K212711
Methodology: https://510kreport.com/methodology