Cleared Special

MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS (K050591) - FDA 510(k) Clearance

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

K050591 · Raven Biological Laboratories, Inc. · General Hospital
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Mar 2005
Decision
15d
Days
Class 2
Risk

K050591 is an FDA 510(k) clearance for the MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Raven Biological Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on March 23, 2005 after a review of 15 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K050591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date March 23, 2005
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRC Indicator, Biological 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.

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