# K221492: SteriTite Container System with MediTray Parts

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Oct 7, 2022 after 137 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.
No later device cites it as a predicate yet.
0 of 8 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 11.

## 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, Non-Lumen and Flexible cycle) - STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle) - STERRAD 100NX ALLCLEAR (Standard, Flexible, DUO and Express 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. The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers: Table 1. SteriTite Container System with MediTray Parts Lumen Claims: Sterilizer Cycle Lumen Sterilization Claims (I.D. x Length) STERIS V-Pro 60 Flexible >1mm x <990mm (Single or Dual Lumen) STERIS V-Pro 60 Lumen >0.77mm x <527mm (Dual Channel) STERIS V-Pro s2 Flexible >Imm x <990mm (Single or Dual Lumen) STERIS V-Pro s2 Lumen >0.77mm x <527mm (Dual Channel) STERIS V-Pro maX 2 Flexible >Imm x <1050mm (Single Lumen) STERIS V-Pro maX 2 Lumen >0.77mm x <527mm (Dual Channel) STERIS V-Pro maX Flexible >Imm x <1050mm (Single Lumen) STERIS V-Pro maX Lumen >0.77mm x <527mm (Dual Channel) STERRAD 100NX DUO >1mm x <875mm (Single Lumen) Sterizone VP4 Cycle 1 >1.2mm x <1955mm (Flexible Lumens) Sterizone VP4 Cycle 1 >1.45mm x <3500mm (Flexible Lumens) Steam Pre-Vac >2mm x <400mm (Stainless Steel Lumen) >1.2mm x <400mm (Flexible Lumen)

Source page: https://510kreport.com/device/K221492
Methodology: https://510kreport.com/methodology