← Back to catalogue

Steam Sterilizer 2545D

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243994

by Ningbo Ican Machines Co., Ltd.

Identifiers

510(k) Number
K243994 FDA 510(k)
FDA Product Code
FLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6880 FDA 510(k)
Regulation Number
880.6880 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Steam Sterilizer 2545D is a Class II medical device designed for steam sterilization of surgical instruments, devices, and supplies. It employs moist heat to eliminate microorganisms, ensuring sterile conditions for healthcare settings by achieving high-temperature, high-pressure cycles that meet regulatory standards for decontamination.

This device is intended for use in general hospital environments and is supplied as a reusable medical instrument. It operates under FDA 510(k) clearance and MDR authorization, adhering to steam sterilization protocols for reusable items. The sterilizer is not MRI-safe and requires proper storage, maintenance, and adherence to manufacturer guidelines to ensure effective and safe operation.

Frequently asked questions

What types of items can the Steam Sterilizer 2545D process, and is it suitable for all hospital departments?

The Steam Sterilizer 2545D is designed for sterilizing surgical instruments, devices, and supplies using moist heat, making it ideal for general hospital environments. While it is intended for reusable items, it is not specified for use in all departments—its primary application is in settings where reusable medical instruments require decontamination, such as operating rooms, surgical suites, or central sterile processing departments. The device adheres to steam sterilization protocols for reusable items, ensuring compliance with regulatory standards for decontamination.

Is the Steam Sterilizer 2545D a single-use or reusable device, and what does that mean for maintenance?

The Steam Sterilizer 2545D is explicitly described as a reusable medical instrument, meaning it is built to be used repeatedly across multiple sterilization cycles. As a reusable device, it requires regular maintenance, cleaning, and adherence to manufacturer guidelines to ensure proper functionality and safety. Proper storage and upkeep are critical to maintaining its performance and longevity in a healthcare setting.

What regulatory pathways has the Steam Sterilizer 2545D followed, and how does that affect its use in hospitals?

The Steam Sterilizer 2545D has undergone FDA 510(k) clearance and MDR authorization, confirming its compliance with regulatory standards for steam sterilization. This means it has been evaluated for safety and effectiveness in decontaminating reusable medical instruments, ensuring it can be reliably used in general hospital environments. Hospitals can trust its adherence to established protocols for sterilization, though they must still follow the manufacturer’s instructions for operation and maintenance.

Does the Steam Sterilizer 2545D require any special handling or storage conditions?

While the device data does not specify exact storage conditions, the manufacturer’s guidelines (referenced in the description) must be followed to ensure proper operation. Since it is a reusable medical instrument, it should be stored in a clean, dry environment away from contaminants and extreme temperatures. Regular maintenance, as outlined by the manufacturer, is essential to prevent malfunctions and ensure consistent sterilization performance.

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
Ningbo Ican Machines Co., Ltd.

Sources (2)

  • FDA 510(k) K243994 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026