Cleared Special

RAVEN PROPACT (K053212) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053212 · Raven Biological Laboratories, Inc. · General Hospital
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Feb 2006
Decision
91d
Days
Class 2
Risk

K053212 is an FDA 510(k) clearance for the RAVEN PROPACT. Classified as Indicator, Biological, Liquid Chemical Sterilization Process (product code MRB), Class II - Special Controls.

Submitted by Raven Biological Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on February 15, 2006 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Raven Biological Laboratories, Inc. devices

Submission Details

510(k) Number K053212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date February 15, 2006
Days to Decision 91 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRB Indicator, Biological, Liquid Chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.