Cleared Special

K123017 - STERRAD CYCLESURE 24 BIOLOGICAL INDICAT...

K123017 is the FDA 510(k) clearance for STERRAD CYCLESURE 24 BIOLOGICAL INDICAT... by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FRC) cleared through the Special 510(k) pathway after a 89-day FDA review.

K123017 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
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Dec 2012
Decision
89d
Days
Class 2
Risk

K123017 is an FDA 510(k) clearance for the STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on December 26, 2012 after a review of 89 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 Advanced Sterilization Products devices

Submission Details

510(k) Number K123017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date December 26, 2012
Days to Decision 89 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 107
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