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STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212200

by Plasmapp Co., Ltd.

Identifiers

510(k) Number
K212200 FDA 510(k)
FDA Product Code
MLR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6860 FDA 510(k)
Regulation Number
880.6860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The STERLINK FPS-15s Plus Sterilizer with STERLOAD Cassette is a chemical sterilizer designed for low-temperature plasma sterilization of medical devices. It employs plasma technology to eliminate microorganisms, ensuring high-level disinfection and sterilization of reusable instruments and devices without damaging heat-sensitive materials. This device is classified as a Class II medical device under FDA regulations, adhering to stringent standards for safety and efficacy in healthcare settings.

This sterilizer is intended for use in general hospital environments, where it processes instruments in a reusable cycle. Supplied as a standalone unit, it requires proper training for operation and maintenance. The device is not single-use and must be maintained according to manufacturer guidelines to ensure consistent performance. Authorized under FDA 510(k) clearance and MDR compliance, it is regulated for use in sterilizing a range of medical devices as specified in its design and validation protocols.

Frequently asked questions

What types of medical devices can the STERLINK™ FPS-15s Plus Sterilizer process, and why is this technology important for healthcare settings?

The STERLINK™ FPS-15s Plus Sterilizer uses low-temperature plasma sterilization to process reusable medical instruments and devices, particularly those made of heat-sensitive materials like plastics or polymers. This technology ensures high-level disinfection and sterilization without heat damage, making it ideal for delicate or temperature-sensitive tools commonly used in general hospital environments. It’s designed for reusable cycles, ensuring compliance with infection control protocols while preserving device integrity.

Is the STERLINK™ FPS-15s Plus Sterilizer meant for single-use, or does it require maintenance and servicing?

The STERLINK™ FPS-15s Plus is not a single-use device—it is built for repeated sterilization cycles in healthcare settings. However, it must be maintained according to the manufacturer’s guidelines to ensure consistent performance and safety. Proper upkeep is critical for reliability, as outlined in the device’s operational and validation protocols.

How is the sterilizer regulated, and what does its classification as a Class II device under FDA standards mean for hospitals?

The STERLINK™ FPS-15s Plus is regulated under FDA 510(k) clearance and MDR compliance, classified as a Class II medical device. This classification indicates it undergoes stringent review for safety and effectiveness, ensuring it meets performance standards for sterilization in general hospital settings. Hospitals benefit from this classification as it confirms the device adheres to rigorous regulatory requirements before use.

What accessories or components are included with the STERLINK™ FPS-15s Plus, and how does the STERLOAD™ Cassette factor into its operation?

The STERLINK™ FPS-15s Plus is supplied as a standalone unit and includes the STERLOAD™ Cassette, which is designed to hold and process medical instruments during sterilization cycles. The cassette ensures organized loading and efficient plasma sterilization, making it easier to handle reusable devices while maintaining the sterilizer’s performance. Training is required for proper use and maintenance of both the unit and cassette.

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: STERLINK™ FPS-15s Plus User Manual, PLASMAPP STERLINK FPS-15S PLUS USER MANUAL Pdf Download, Sterlink FPS-15s Plus Low Temperature Plasma Sterilizer, PLASMAPP STERLINK FPS-15S PLUS USER MANUAL Pdf Download

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Plasmapp Co., Ltd.
FDA Applicant
Plasmapp Co,., Ltd.

Sources (2)

  • FDA 510(k) K212200 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026