Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)

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

510(k) Number

K031152 ↗

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

• Bio-Challenge Test Pak

  Class II

  FDA 510(k) K851804 Active Cleared 16 Jul 1985

• 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

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

• What is the Propper Vapor Line PCD used for in a sterilization process?

  The Propper Vapor Line PCD is a Steam Sterilization Process Challenge Device designed to verify the effectiveness of steam sterilization cycles in pre-vacuum sterilizers. It detects potential process failures—such as inadequate temperature, pressure, or exposure time—ensuring that sterilization parameters meet regulatory and clinical standards for medical instruments and supplies.

• Is the Propper Vapor Line PCD single-use or reusable, and how should it be handled?

  The Propper Vapor Line PCD is reusable and must be processed through the sterilizer alongside the load being tested. It is not sterile upon receipt, so it follows standard hospital reprocessing procedures before use. This aligns with its design for high-volume sterilization environments.

• What type of sterilizers is this device compatible with, and what temperature does it require?

  The Propper Vapor Line PCD is specifically designed for pre-vacuum sterilizers operating at 273.2°F (134°C). It is used in conjunction with a steam sterilization integrator to validate cycle performance under these conditions.

• How is the regulatory status of this device determined, and what class does it fall under?

  The Propper Vapor Line PCD holds FDA 510(k) clearance (K031152) and is classified as Device Class II under the regulatory category 880.2800 (Physical/Chemical Sterilization Process Indicator). This classification reflects its role as a critical component for ensuring sterilization integrity in medical settings.

• What should I consider when storing the Propper Vapor Line PCD between uses?

  Since the device is reusable, storage follows standard hospital reprocessing procedures. It should be kept in a clean, dry environment—free from contaminants—until ready for reprocessing and reuse in sterilization cycles. No additional sterility guarantees are provided upon receipt.