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Celerity 20 Steam Biological Indicator for IUSS

by Steris Corporation

510(k) K202721

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202721 Date8 Jan 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRC
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Celerity 20 Steam Biological Indicator is a device used to monitor the effectiveness of steam sterilization processes. It is designed to provide a reliable indication of whether sterilization conditions have been met by containing a specific microorganism that is resistant to steam sterilization.

This device is intended for use in healthcare settings and is supplied as a single-use product. It is not MRI compatible and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with product code FRC and is classified as a Class II device for biological sterilization process indicators.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Celerity 20 Steam Biological Indicator used for?

    The Celerity 20 Steam Biological Indicator is designed to monitor the effectiveness of steam sterilization processes in healthcare settings. It contains a specific microorganism resistant to steam sterilization to provide reliable indication of whether sterilization conditions have been met.

  • Is the Celerity 20 Steam Biological Indicator single-use or reusable?

    The Celerity 20 Steam Biological Indicator is supplied as a single-use product and should not be reused. Each device is designed for one-time monitoring of a sterilization cycle to ensure accurate results.

  • What is the regulatory status of the Celerity 20 Steam Biological Indicator?

    The Celerity 20 Steam Biological Indicator has received FDA 510(k) clearance with product code FRC and is classified as a Class II device for biological sterilization process indicators. It is not MRI compatible and should be stored according to the manufacturer's instructions.

  • What healthcare settings is the Celerity 20 Steam Biological Indicator intended for?

    The Celerity 20 Steam Biological Indicator is intended for use in healthcare settings, particularly in general hospital environments where steam sterilization processes need to be monitored for effectiveness and patient safety.