Cleared Special

K122044 - STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR

K122044 is an FDA 510(k) clearance for STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 84-day FDA review.

K122044 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
84d
Days
Class 2
Risk

K122044 is an FDA 510(k) clearance for the STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR. 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 October 4, 2012 after a review of 84 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.

FDA 510(k) Submission Details - K122044

510(k) Number K122044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2012
Decision Date October 04, 2012
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

FRC Device Classification - Class 2, Special Controls

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 196
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Download PDF FDA Summary Advanced Sterilizatio…