# K173259: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Jun 13, 2018 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: 2 generations back to K871202 (1987). 5 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products, Case Medical, Inc. (2003) Summary page 6.

## Most influential descendants
- K212711: SteriTite Container System with MediTray Products (2022), 3 descendants of its own
- 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 system with MediTray® products is a rigid reusable sealed sterilization container system used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. The container consists of a solid or a perforated base, perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use. The SteriTite® container has been validated for prevacuum sterilization at 132°C for 4 minutes. with 3 stainless steel (3mm inner diameter × 400mm length) and 3 porous lumens (2mm inner diameter × 400mm length), and representative products of the MediTray line of accessories such as: insert boxes, multilevel tray systems, instrument baskets (stacked and single level) with various inserts including brackets, posts, and partitions. The container may be used for sterilization of medical devices including full instrument sets, stacked trays, and mixed loads. Additionally, the SteriTite® container has been validated for prevacuum sterilization at 134°C for 4 minutes using tabletop autoclaves for metal instrument loads with 5 stainless steel lumen (2mm ID × 250mm length). The following claims have been validated for this device: • One (1) Year sterile shelf life/maintenance of sterility claim: • Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units. • Compatibility with Table Top Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer. The SteriTite® container system is recommended to be used for sterilization of medical devices. Please see tables 1 and 2 below for the recommended total weight of SteriTite® containers with contents in steam sterilization: Table 1: Recommended Load for SteriTite® Containers in Steam Sterilization: Part Number Description Total weight load including container SC02M Mini Size 2”H – Solid Bottom 6 lbs. ( 2.7 kg ) SC02MG Mini Size 2”H – Perforated Bottom 6 lbs. ( 2.7 kg ) SC03M Mini Size 3”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC03MG Mini Size 3”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC04M Mini Size 4”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC04MG Mini Size 4”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC02N ¾ Mini Size 2”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC02NG ¾ Mini Size 2”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC03N ¾ Mini Size 3”H – Solid Bottom 10 lbs. ( 4.5 kg ) SC03NG ¾ Mini Size 3”H – Perforated Bottom 10 lbs. ( 4.5 kg ) SC04H ½ Size 4”H – Solid Bottom 12 lbs. ( 5.4 kg ) SC04HG ½ Size 4”H – Perforated Bottom 12 lbs. ( 5.4 kg ) SC05H Half Size 5”H – Solid Bottom 12 lbs. ( 5.4 kg ) SC05HG Half Size 5”H – Perforated Bottom 12 lbs. ( 5.4 kg ) SC06H ½ Size 6”H – Solid Bottom 14 lbs. ( 6.4 kg ) SC06HG ½ Size 6”H – Perforated Bottom 14 lbs. ( 6.4 kg ) SC08H ½ Size 8”H – Solid Bottom 16 lbs. ( 7.3 kg ) SC08HG ½ Size 8”H – Perforated Bottom 16 lbs. ( 7.3 kg ) SC04Q ¾ Size 4”H – Solid Bottom 18 lbs. ( 8.2 kg ) SC04QG ¾ Size 4”H – Perforated Bottom 18 lbs. ( 8.2 kg ) SC05Q ¾ Size 5”H – Solid Bottom 22 lbs. ( 10.0 kg ) SC05QG ¾ Size 5”H – Perforated Bottom 22 lbs. ( 10.0 kg ) SC06Q ¾ Size 6”H – Solid Bottom 22 lbs. ( 10.0 kg ) SC06QG ¾ Size 6”H – Perforated Bottom 22 lbs. ( 10.0 kg ) SC08Q ¾ Size 8”H – Solid Bottom 25 lbs. ( 11.3 kg ) SC08QG ¾ Size 8”H – Perforated Bottom 25 lbs. ( 11.3 kg ) SC04F Full Size 4”H – Solid Bottom 25 lbs. ( 11.3 kg ) SC04FG Full Size 4”H – Perforated Bottom 25 lbs. ( 11.3 kg ) SC05F Full Size 5”H – Solid Bottom 25 lbs. ( 11.3 kg ) SC05FG Full Size 5”H – Perforated Bottom 25 lbs. ( 11.3 kg ) SC06F Full Size 6”H – Solid Bottom 25 lbs. ( 11.3 kg ) SC06FG Full Size 6”H – Perforated Bottom 25 lbs. ( 11.3 kg ) SC08F Full Size 8”H – Solid Bottom 25 lbs. ( 11.3 kg ) SC08FG Full Size 8”H – Perforated Bottom 25 lbs. ( 11.3 kg ) SC04L Long Size 4"H – Solid Bottom 30 lbs. ( 13.6 kg ) SC04LG Long Size 4"H – Perforated Bottom 30 lbs. ( 13.6 kg ) SC06L Long Size 6"H – Solid Bottom 30 lbs. ( 13.6 kg ) SC06LG Long Size 6"H – Perforated Bottom 30 lbs. ( 13.6 kg ) SC08L Long Size 8"H – Solid Bottom 30 lbs. ( 13.6 kg ) SC08LG Long Size 8"H – Perforated Bottom 30 lbs. ( 13.6 kg ) Table 2. Recommended Load and Sizing for SteriTite® Containers for Table Top Sterilizers Part Number Description Total weight load including container SC02M Mini Size 2”H – Solid Bottom 6 lbs. ( 2.7 kg ) SC02MG Mini Size 2”H – Perforated Bottom 6 lbs. ( 2.7 kg ) SC03M Mini Size 3”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC03MG Mini Size 3”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC04M Mini Size 4”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC04MG Mini Size 4”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC02N ¾ Mini Size 2”H – Solid Bottom 8 lbs. ( 3.6 kg ) SC02NG ¾ Mini Size 2”H – Perforated Bottom 8 lbs. ( 3.6 kg ) SC03N ¾ Mini Size 3”H – Solid Bottom 10 lbs. ( 4.5 kg ) SC03NG ¾ Mini Size 3”H – Perforated Bottom 10 lbs. ( 4.5 kg )

Source page: https://510kreport.com/device/K173259
Methodology: https://510kreport.com/methodology