ProChem EXT Chemical Integrator

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

510(k) Number

K062651 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Raven Biological Laboratories, Inc. →

• What is the primary purpose of the ProChem EXT Chemical Integrator?

  This device is an integrating chemical indicator designed to monitor the efficacy of steam sterilization cycles, ensuring that the required conditions for sterilization have been met.

• Which sterilization cycles is this integrator indicated for?

  It is indicated for use in gravity displacement cycles at 121°C for 20 minutes, as well as prevacuum cycles at 121°C for 20 minutes, 132°C for 8.5 minutes, 134°C for 7.5 minutes, and 135°C for 7 minutes.

• What is the regulatory status of this device?

  The ProChem EXT Chemical Integrator is authorized under FDA 510(k) clearance and is categorized under regulation number 880.2800 for physical and chemical sterilization process indicators.