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Bi-O.K. EO Gas Biological Test-Pak (269305, 269310, 269320)

by Propper Mfg. Co., Inc.

510(k) K972747

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 NumberK972747 Date9 Jan 1998ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

Bi-O.K. EO Gas Biological Test-Pak is a biological indicator device used for monitoring ethylene oxide sterilization processes. It is designed as a disposable test pack containing vials with bacterial spores to verify the effectiveness of sterilization cycles in healthcare facilities.

The device is supplied as a single-use product and is activated after the ethylene oxide cycle by crushing a glass ampoule to release spores into nutrient media for incubation. It is intended for use in general hospital settings and is regulated under FDA 510(k) clearance K972747 with product code FRC and regulation number 880.2800.

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Questions

AI-generated answers, 25 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 BI-O.K. EO Gas Biological Test-Pak used for?

    The BI-O.K. EO Gas Biological Test-Pak is used to monitor the effectiveness of ethylene oxide sterilization processes by containing bacterial spores that are incubated after exposure to verify sterilization success in healthcare facilities.

  • How is the BI-O.K. EO Gas Biological Test-Pak supplied and used?

    The device is supplied as a single-use disposable test pack containing vials with bacterial spores; it is activated after the ethylene oxide cycle by crushing an internal glass ampoule to release spores into nutrient media for incubation.

  • Is the BI-O.K. EO Gas Biological Test-Pak reusable or single-use?

    The BI-O.K. EO Gas Biological Test-Pak is designed as a single-use product and is not intended for reuse; it is discarded after activation and incubation to ensure accurate and uncontaminated test results.