← Back to catalogue

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for ST…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220345

by Plasmapp Co., Ltd.

Identifiers

510(k) Number
K220345 FDA 510(k)
FDA Product Code
MLR FDA 510(k)
Models / Variants
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer FDA 510(k)EUDAMED
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) FDA 510(k)EUDAMED

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)

This system combines a sterilizer and chemical sterilization accessories for hospital use. The STERLINK Mini Sterilizer employs a chemical sterilization process, while the associated components—STERLOAD mini cassettes, Tyvek rolls with chemical indicators (CI), and sterilization process indicators—ensure proper sterilization tracking and packaging. Additional devices include incubators (Bionova SCBI and Reader models), a chemdye system (CD42), and a tape dispenser (Cintape CT40) for laboratory or clinical use.

The STERLINK Mini Sterilizer is designed for single-use or reusable medical devices in general hospital settings, with non-sterile components requiring sterilization before use. Supplied as a Class II device under FDA 510(k) clearance and MDD compliance, it operates in controlled environments where chemical sterilization is required. Components like the Bionova incubators and Chemdye system are intended for in vitro diagnostic or laboratory applications, adhering to regulatory standards for chemical and biological safety. Storage and handling follow manufacturer guidelines to maintain efficacy and sterility.

Frequently asked questions

What types of medical devices can be sterilized using the STERLINK Mini Sterilizer, and how does it differ from traditional steam sterilization?

The STERLINK Mini Sterilizer uses a chemical sterilization process, making it suitable for single-use or reusable medical devices that cannot withstand heat or moisture—such as certain plastics, adhesives, or temperature-sensitive materials. Unlike steam sterilization, which relies on high heat and pressure, this system employs chemical agents to achieve sterilization in controlled hospital environments. It is specifically designed for general hospital use where chemical sterilization is required, as noted in the regulatory filings.

Are the STERLOAD mini Cassettes and Tyvek rolls with chemical indicators meant for single-use, or can they be reused?

The STERLOAD mini Cassettes and Tyvek rolls with chemical indicators (CI) are intended for single-use in the sterilization process. Their purpose is to ensure proper packaging and tracking of sterilized items, with the chemical indicators verifying the sterilization cycle’s effectiveness. Reusing these components could compromise sterility and the accuracy of sterilization verification, so adherence to single-use guidelines is critical.

What are the key components of the Terragene Bionova incubators (e.g., BT96, IC10/20FRLCD), and how are they regulated?

The Terragene Bionova incubators (such as the BT96 and IC10/20FRLCD models) are designed for in vitro diagnostic or laboratory applications, including biological safety and incubation of samples. These devices are part of the broader system and are regulated under FDA 510(k) clearance and MDD compliance, ensuring they meet safety and performance standards for controlled environments. They are not intended for direct patient treatment but support clinical or diagnostic workflows.

How should the STERLINK Mini Sterilizer and its accessories be stored to maintain their effectiveness and sterility?

The STERLINK Mini Sterilizer and its accessories (e.g., STERLOAD cassettes, Tyvek rolls, and sterilization indicators) must be stored in a clean, dry environment as per the manufacturer’s guidelines. Non-sterile components requiring sterilization should be handled aseptically before use, while sterile items should remain in sealed packaging until deployment. Improper storage could degrade chemical indicators or compromise the integrity of the sterilization process.

What regulatory pathways were followed for the STERLINK Mini Sterilizer, and how does this affect its use in hospitals?

The STERLINK Mini Sterilizer was cleared via FDA 510(k) under Traditional Review and complies with MDD (Medical Device Directive) standards, confirming its safety and effectiveness for chemical sterilization in general hospital settings. This regulatory route ensures the device meets established performance criteria for chemical sterilization, allowing hospitals to integrate it into their workflows for non-sterile medical device preparation while adhering to clinical and administrative protocols.

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

MDD

United States Active

FDA_510K

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

Manufacturer

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

Sources (2)

  • FDA 510(k) K220345 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026