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Acecide High-Level Disinfectant and Sterilant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041984

by Best Sanitizers, Inc.

Identifiers

510(k) Number
K041984 FDA 510(k)
FDA Product Code
MED FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6885 FDA 510(k)
Regulation Number
880.6885 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Acecide-C is a room temperature, peracetic acid-based liquid chemical germicide designed for high-level disinfection and sterilization of clean, heat-sensitive, critical, and semi-critical medical devices. It is intended for use with the Olympus OER-Pro system, where Solutions 1 and 2 are automatically combined with water to create the use-solution. The device is proven for material compatibility by Olympus for Olympus endoscopes.

Acecide-C is supplied as a set loaded into the disinfectant drawer of the OER-Pro system. It is a single-use chemical sterilant that operates at room temperature with peracetic acid as the biocidal agent. The device is FDA 510(k) cleared with product code MED and is regulated for automated sterilization or high-level disinfection of medical devices not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.

Frequently asked questions

What is Acecide-C used for?

Acecide-C is designed for high-level disinfection and sterilization of clean, heat-sensitive, critical, and semi-critical medical devices, particularly when used with the Olympus OER-Pro system.

How is Acecide-C supplied?

Acecide-C is supplied as a set loaded into the disinfectant drawer of the OER-Pro system, where Solutions 1 and 2 are automatically combined with water to create the use-solution.

Is Acecide-C single-use or reusable?

Acecide-C is a single-use chemical sterilant that operates at room temperature with peracetic acid as the biocidal agent.

What is the regulatory status of Acecide-C?

Acecide-C is FDA 510(k) cleared with product code MED and is regulated for automated sterilization or high-level disinfection of medical devices not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.

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: Acecide-C | Olympus America | Medical, PDF Acecide-C High-Level Disinfectant - Olympus America, ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT (K041984) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Best Sanitizers, Inc.

Sources (1)

  • FDA 510(k) K041984 24 fields · synced Sep 22, 2026