Prospore II

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

510(k) Number

K971430 ↗

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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  FDA 510(k) K031114 Active Cleared 3 Mar 2004

• Raven Propact

  Class II

  FDA 510(k) K053212 Active Cleared 15 Feb 2006

• Modification to:raven Bacterial Spore Strips Open recall

  Class II

  FDA 510(k) K032914 Active Cleared 25 May 2004

• Prospore II

  Class II

  FDA 510(k) K960790 Active Cleared 16 Aug 1996

• Raven Protest - Steam Biological Indicator

  Class II

  FDA 510(k) K082756 Active Cleared 21 Oct 2009

• Modification to Raven Bacterial Spore Strips Open recall

  Class II

  FDA 510(k) K050591 Active Cleared 23 Mar 2005

See all devices from Raven Biological Laboratories, Inc. →

• What is the Prospore II used for in a hospital setting?

  The Prospore II is a self-contained biological indicator specifically designed to validate the effectiveness of steam sterilization processes at 121°C. It ensures that sterilization cycles achieve the required microbial lethality standards, helping confirm that medical instruments and supplies are properly sterilized before reuse.

• Is the Prospore II intended for single-use or reusable applications?

  The Prospore II is explicitly labeled as a single-use biological indicator. After use, it should be discarded to avoid contamination or inaccurate results in subsequent sterilization validations.

• How is the Prospore II supplied, and what does the packaging look like?

  The Prospore II is supplied as a non-sterile indicator housed in a plastic tube with a cap. The packaging is simple and functional, designed for easy handling and storage in standard hospital settings.

• Are there any special storage requirements for the Prospore II beyond standard biological indicator protocols?

  No additional storage restrictions are noted beyond following standard biological indicator protocols. The device should be stored in a way that maintains its integrity until use, ensuring it remains effective for validating steam sterilization cycles.

• What regulatory pathway was followed for the FDA clearance of the Prospore II?

  The Prospore II received FDA 510(k) clearance under product code FRC, classified as a Class II device. The clearance was granted through a traditional review process, with the device deemed substantially equivalent to a predicate. The authorization was filed under the General Hospital advisory committee (HO) and received clearance on May 22, 1997.