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Cyclesure Test Pack

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051643

by Advanced Sterilization Products

Identifiers

510(k) Number
K051643 FDA 510(k)
FDA Product Code
FRC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cyclesure Test Pack is a biological indicator designed for monitoring hydrogen peroxide gas plasma sterilization cycles. It serves as a challenge device to validate the effectiveness of sterilization processes, ensuring microbial inactivation within the specified parameters.

This test pack is supplied as a single-use, non-sterile component intended for use with the STERRAD Sterilizer system. It includes a self-contained biological/chemical indicator, a vial with an orifice, and a vial cap, packaged in a protective pouch. Authorized under FDA 510K clearance (K051643), it adheres to Class II medical device regulations (21 CFR 880.2800) and is intended for general hospital use.

Frequently asked questions

What is the Cyclesure Test Pack used for in a hospital setting?

The Cyclesure Test Pack is a biological indicator specifically designed to validate the effectiveness of hydrogen peroxide gas plasma sterilization cycles in the STERRAD Sterilizer system. It acts as a challenge device to confirm microbial inactivation during sterilization, ensuring that the process meets its intended parameters for safety and reliability in general hospital environments.

Is the Cyclesure Test Pack intended for reuse or is it single-use?

The Cyclesure Test Pack is explicitly labeled as a single-use component. Each pack is non-sterile and meant to be discarded after one use, ensuring accurate validation of sterilization cycles without carryover risks.

What does the packaging of the Cyclesure Test Pack include, and how is it protected?

The Cyclesure Test Pack comes in a self-contained format that includes a biological/chemical indicator, a vial with an orifice, and a vial cap, all housed within a protective pouch. This packaging ensures the integrity of the components until use.

How is the Cyclesure Test Pack regulated, and what does its FDA clearance indicate?

The Cyclesure Test Pack is cleared under FDA 510K (K051643) as a Class II medical device, adhering to 21 CFR 880.2800. The clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, meaning it meets regulatory standards for safety and effectiveness as a biological indicator for hydrogen peroxide gas plasma sterilization validation.

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: STERRAD STERILIZER CYCLESURE TEST PACK - Innolitics, STERRAD 50/100S/200 TEST PACK by ADVANCED STERILIZATION PRODUCTS | FDA ..., STERRAD™ 100NX System with ALLClear™ Technology - ASP, Sterilization Monitoring - ASP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Sterilization Products

Sources (1)

  • FDA 510(k) K051643 24 fields · synced Sep 19, 2026