ASSERT Biological/Chemical Indicator

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

Full name

Assert Tm Biological/Chemical Indicator

510(k) Number

K855101 ↗

FDA Product Code

FRC

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 Surgicot, Inc. →

• What is the ASSERT Biological/Chemical Indicator used for?

  This device is a Biological Sterilization Process Indicator intended to verify the effectiveness of sterilization cycles in autoclaves and other sterilization equipment within general hospital settings. It provides visual confirmation that biological and chemical challenges within the process have been met.

• Is the ASSERT Biological/Chemical Indicator intended for single use?

  Yes, the device is designed as a single-use indicator. It is supplied in sterile packaging and is intended to be used once per sterilization cycle.

• How is the device supplied and stored?

  The device is supplied in sterile packaging. It requires no special storage conditions beyond protection from contamination.

• What is the regulatory status of the ASSERT Biological/Chemical Indicator?

  The device holds FDA 510(k) clearance (K855101) under the Substantially Equivalent determination and is classified as a Class II medical device.