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Sporview Rapid Read Biological Indicator Steamplus Test Pack

by Crosstex/Spsmedical, A Division of Cantel Medical

510(k) K181434

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 NumberK181434 Date14 Nov 2018ClearedStatusActive

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  • Withdrawn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, 28 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 Sporview Rapid Read Biological Indicator Steamplus Test Pack is a biological indicator used for routine monitoring and sterilizer qualification testing of steam sterilization cycles. It is designed for use in both gravity and prevacuum sterilizers. The device provides final results in 10 hours when incubated at 55-60°C.

The Sporview Rapid Read Biological Indicator Steamplus Test Pack is supplied with a Steamplus Sterilization Integrator and is intended for use in general hospital settings. It is regulated under FDA 510K and has a product code of FRC, with a regulation number of 880.2800. The device is available with multiple FEI numbers and registration numbers, and is used for immediate release of non-implant loads.

Other devices from Crosstex/Spsmedical, A Division of Cantel Medical

Questions

AI-generated answers, 28 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 SporView Rapid Read Biological Indicator Steamplus Test Pack used for?

    The SporView Rapid Read Biological Indicator Steamplus Test Pack is used for routine monitoring and sterilizer qualification testing of steam sterilization cycles in general hospital settings.

  • How is the SporView Rapid Read Biological Indicator Steamplus Test Pack supplied?

    The SporView Rapid Read Biological Indicator Steamplus Test Pack is supplied with a Steamplus Sterilization Integrator.

  • What are the incubation conditions for the SporView Rapid Read Biological Indicator Steamplus Test Pack?

    The SporView Rapid Read Biological Indicator Steamplus Test Pack provides final results in 10 hours when incubated at 55-60°C.

  • Is the SporView Rapid Read Biological Indicator Steamplus Test Pack regulated?

    The SporView Rapid Read Biological Indicator Steamplus Test Pack is regulated under FDA 510K with a product code of FRC and a regulation number of 880.2800.