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Verify Sirius Biological Indicator Challenge Pack

by Steris Corporation

510(k) K073618

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 NumberK073618 Date7 Jan 2009ClearedStatusActive

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  • Withdrawn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, 19 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 Verify Sirius Biological Indicator Challenge Pack is a biological indicator used to assess the effectiveness of vaporized hydrogen peroxide (VH2O2) sterilization processes. It is designed for qualification testing of the Amsco V-PRO™ 1 Low Temperature Sterilization System following installation, relocation, malfunctions, or major repairs.

Supplied by STERIS Corporation, this device is classified as a Class II medical device under product code FRC and regulation number 880.2800. It received FDA 510(k) clearance (K073618) on January 7, 2009, and is intended for use in general hospital settings to monitor sterilization process efficacy.

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See all devices from Steris Corporation →

Questions

AI-generated answers, 19 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 Verify Sirius Biological Indicator Challenge Pack used for?

    The Verify Sirius Biological Indicator Challenge Pack is used to assess the effectiveness of vaporized hydrogen peroxide (VH2O2) sterilization processes, specifically for qualification testing of the Amsco V-PRO™ 1 Low Temperature Sterilization System following installation, relocation, malfunctions, or major repairs.

  • Who manufactures the Verify Sirius Biological Indicator Challenge Pack?

    The Verify Sirius Biological Indicator Challenge Pack is supplied by STERIS Corporation, which is also the manufacturer listed in the device data.

  • How was the Verify Sirius Biological Indicator Challenge Pack cleared for market?

    The device received FDA 510(k) clearance (K073618) on January 7, 2009, through a traditional submission pathway, and was found to be substantially equivalent to a predicate device.

  • What regulatory classification does the Verify Sirius Biological Indicator Challenge Pack have?

    The device is classified as a Class II medical device under product code FRC and regulation number 880.2800, as indicated in the device data.

  • In what type of setting is the Verify Sirius Biological Indicator Challenge Pack intended to be used?

    The device is intended for use in general hospital settings to monitor sterilization process efficacy, as stated in the device description.