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Sterrad Cyclesure 24 Plus Biological Indicator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140589

by Mesa Laboratories, Inc.

Identifiers

510(k) Number
K140589 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 STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR is a biological indicator used to monitor the effectiveness of STERRAD sterilization processes. It contains a glass fiber disc with a minimum of 1x10^6 Geobacillus stearothermophilus spores and a glass ampoule of nutrient growth medium, serving as a self-contained, stand-alone monitor for STERRAD systems.

This device is intended for use in healthcare facilities as a standard method for frequent monitoring of STERRAD sterilizer systems. It is supplied as a single-use indicator and is regulated under FDA 510(k) clearance K140589, classified as a Class II device with product code FRC and regulation number 880.2800.

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 CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (K140589) — FDA 510 (k ..., CYCLESURE® 24 Biological Indicator (BI) | ASP, STERRAD CYCLESURE 24 Biological Indicator (K151971) — FDA 510 (k ..., Class 2 Device Recall STERRAD CYCLESURE 24 Biological Indicator, 510k.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mesa Laboratories, Inc.

Sources (1)

  • FDA 510(k) K140589 24 fields · synced Sep 22, 2026