Attest Brand Rapid Readout Biological Indicator #129X

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

Full name

Attest Brand Rapid Readout Biological Ind. #129X

510(k) Number

K926364 ↗

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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• What is the Attest Brand Rapid Readout Biological Indicator #129X used for?

  The Attest Brand Rapid Readout Biological Indicator #129X is designed to confirm the effectiveness of sterilization processes by verifying that microbial spores are inactivated during each cycle. This ensures sterile conditions in medical environments, particularly in general hospital settings, where reliable sterilization is critical for patient safety.

• How is the Attest Brand Rapid Readout Biological Indicator #129X supplied, and what are its storage requirements?

  The device is supplied sterile and intended for single-use per sterilization cycle. Storage requires only protection from physical damage and contamination—no special environmental conditions are needed. This simplicity ensures ease of use in clinical settings.

• Is the Attest Brand Rapid Readout Biological Indicator #129X reusable, or is it meant for one-time use?

  This indicator is explicitly designed for one-time use per sterilization cycle. After use, it should be discarded to maintain accuracy and compliance with sterilization validation protocols. Reuse could compromise its reliability in detecting microbial inactivation.

• What regulatory pathway does the Attest Brand Rapid Readout Biological Indicator #129X follow?

  The device is classified under FDA 510(k) clearance (K926364) and adheres to Class II special controls for biological indicators (regulation 880.2800). This pathway ensures it meets stringent performance standards for sterilization verification in medical environments.

• Are there different models or sizes available for the Attest Brand Rapid Readout Biological Indicator?

  The provided data specifies only the #129X model, which is a single-use biological indicator for general hospital sterilization processes. No alternative models or sizes are referenced in the available documentation, so this is the standard offering for this product line.