← Back to catalogue

Sonopet iQ Sterilization Tray

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190667

by Paragon Medical

Identifiers

510(k) Number
K190667 FDA 510(k)
FDA Product Code
KCT 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 Sonopet iQ Sterilization Tray is a sterilization tray designed to hold and protect ultrasound transducers during high-level disinfection and sterilization processes. It ensures proper orientation and prevents damage to the transducer while maintaining compliance with medical sterilization protocols.

This tray is intended for use in general hospital settings and is supplied as a reusable device. It is compatible with standard sterilization methods, including autoclave and chemical sterilization, and is regulated under FDA 510K clearance (K190667) and MDR. The device is not classified as MRI-safe or unsafe, and its dimensions or specific size variants are not detailed in the provided data.

Frequently asked questions

What is the primary purpose of the Sonopet iQ Sterilization Tray, and how does it protect ultrasound transducers during sterilization?

The Sonopet iQ Sterilization Tray is designed to securely hold and protect ultrasound transducers during high-level disinfection and sterilization processes. It ensures proper orientation of the transducer to prevent damage while adhering to medical sterilization protocols, making it ideal for use in general hospital settings.

Is the Sonopet iQ Sterilization Tray intended for single-use or reusable applications, and what sterilization methods does it support?

The Sonopet iQ Sterilization Tray is explicitly labeled as a reusable device, meaning it can be used multiple times after proper cleaning and sterilization. It is compatible with standard sterilization methods, including autoclave and chemical sterilization, ensuring flexibility for different hospital workflows.

How is the regulatory status of the Sonopet iQ Sterilization Tray determined, and what does this mean for its use in clinical settings?

The Sonopet iQ Sterilization Tray holds FDA 510K clearance (K190667) and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device. This clearance confirms its safety and effectiveness for its intended use in general hospital settings, ensuring it meets established medical standards for sterilization trays.

Can the Sonopet iQ Sterilization Tray be used in MRI environments, and what considerations should be taken into account?

The provided data does not classify the Sonopet iQ Sterilization Tray as MRI-safe or MRI-unsafe, meaning its compatibility with MRI environments is not explicitly addressed. Clinicians should verify its use in MRI settings based on the materials and construction of the tray itself, as well as the specific MRI system’s guidelines, to avoid interference or safety risks.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Paragon Medical

Sources (2)

  • FDA 510(k) K190667 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026