Bio-Challenge Test Pak

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

510(k) Number

K851804 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ok Flash Sterilization Indicator

  Class II

  FDA 510(k) K834353 Active Cleared 19 Mar 1984

• Bi-O.K.(Tm)-Biological/Chemical Indicator

  Class II

  FDA 510(k) K891784 Active Cleared 9 Feb 1990

• Once-A-Day Vertos Test Pack

  Class II

  FDA 510(k) K082620 Active Cleared 8 Jul 2009

• Propper Super Seracult(R)

  Class II

  FDA 510(k) K921798 Active Cleared 5 Oct 1992

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

  Class II

  FDA 510(k) K972747 Active Cleared 9 Jan 1998

• Pass/Fail Challenge Pack

  Class II

  FDA 510(k) K991276 Active Cleared 12 Jul 1999

See all devices from Propper Mfg. Co., Inc. →

• What is the Bio-Challenge Test Pak used for?

  The Bio-Challenge Test Pak is a biological indicator designed specifically to monitor and validate the effectiveness of physical and chemical sterilization processes, particularly steam sterilization. It helps hospitals confirm that their sterilization cycles are functioning correctly, ensuring that medical instruments and supplies are properly sterilized before use.

• How is the Bio-Challenge Test Pak supplied, and is it reusable?

  The Bio-Challenge Test Pak is supplied as a pre-assembled, single-use kit. This means each package is intended for one-time use only and cannot be reused. The single-use design ensures accuracy and reliability in sterilization validation, as reuse could compromise the integrity of the indicator.

• Does the Bio-Challenge Test Pak have MRI safety specifications?

  No, the Bio-Challenge Test Pak does not have MRI safety specifications. It is designed exclusively for sterilization validation purposes and should not be used in or near MRI environments.

• What regulatory approval does the Bio-Challenge Test Pak hold?

  The Bio-Challenge Test Pak holds an FDA 510(k) clearance with the clearance number K851804. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and is regulated under product code JOJ and regulation number 880.2800.

• Are there different models or sizes available for the Bio-Challenge Test Pak?

  The provided data does not specify multiple models or sizes for the Bio-Challenge Test Pak. It is described as a singular biological indicator kit for general hospital sterilization validation. For specific configurations or additional variants, consult the manufacturer’s detailed product documentation.