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SteriTite Containers System & MediTray Products

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161415

by Case Medical Inc

Identifiers

510(k) Number
K161415 FDA 510(k)
FDA Product Code
FRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SteriTite Containers System with MediTray inserts is a reusable rigid sterilization container system designed for instrument reprocessing. It provides a universal sealed container that can accommodate a wide range of medical devices and includes modular MediTray inserts for organized placement of instruments.

The system is cleared under FDA 510(k) (K161415) as a traditionally cleared, substantially equivalent device (product code FRG). It is supplied as a reusable, universal container compatible with all sterilization modalities and is offered with either a perforated base for general use or a solid base for pre‑vacuum steam cycles. The device is marketed by Case Medical, Inc. and is identified as a reusable packaging solution for hospital instrument processing.

Frequently asked questions

What is the SteriTite Containers System & MediTray Products used for?

The SteriTite Containers System with MediTray inserts is designed for instrument reprocessing, providing a universal sealed container that accommodates a wide range of medical devices and includes modular MediTray inserts for organized placement of instruments during sterilization and storage.

How is the SteriTite Containers System supplied and is it reusable?

The system is supplied as a reusable, universal rigid sterilization container, compatible with all sterilization modalities, and is offered with either a perforated base for general use or a solid base for pre‑vacuum steam cycles, allowing repeated use after proper cleaning and sterilization.

What regulatory pathway was used for the SteriTite Containers System & MediTray Products?

The device was cleared under the FDA 510(k) pathway (K161415) as a traditionally cleared, substantially equivalent device under product code FRG, meaning it was found to be substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sterilization Containers - Case Medical, Case Medical, CaseMed SteriTite - Universal Sterilization Container System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Case Medical Inc
FDA Applicant
Case Medical, Inc.

Sources (1)

  • FDA 510(k) K161415 24 fields · synced Sep 24, 2026