Cleared Special

K053212 - RAVEN PROPACT

K053212 is an FDA 510(k) clearance for RAVEN PROPACT, manufactured by Raven Biological Laboratories, Inc.. The device is a Class 2 General Hospital device with product code MRB cleared through the Special 510(k) pathway after a 91-day FDA review.

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.

FDA 510(k) Submission Details - K053212

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

MRB Device Classification - Class 2, Special Controls

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.

K053212 · RAVEN PROPACT
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