# K161415: SteriTite Containers System & MediTray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Feb 10, 2017 after 263 days
- Product code: FRG (Wrap, Sterilization)
- 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 K040865 (2004). 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)
- K090068: Steritite Universal Container System and Meditray Products, Case Medical, Inc. (2010) Summary page 5.
- K112904: Steritec Containers System & Meditray Products, Case Medical, Inc. (2012) Summary page 5.
- K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl, Case Medical, Inc. (2000) Summary page 5.
- K030853: Steritite Perforated Base Rigid Reusable Sterilization Container System with SCF02-Polypropylene Non-Woven Disposable FI, Case Medical, Inc. (2003) Summary page 5.
- K080558: Steritite Container System & Meditray Products, Case Medical, Inc. (2008) Summary page 5.
- K110682: Steritite Container System & Meditray Products, Case Medical, Inc. (2011) Summary page 5.

## Indications for use
The SteriTite® container system with MediTray products is a reusable 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 perforated base and perforated lid with filter retention plates, and disposable polypropylene filters. The Case Medical’s SteriTite® container system and MediTray products are compatible with the TSO3 Inc.’s STERIZONE® VP4 Cycle 1 sterilization system for blades, lumened devices and flexible endoscopes.

Source page: https://510kreport.com/device/K161415
Methodology: https://510kreport.com/methodology