Cleared Traditional

K102884 - STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR

K102884 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 Traditional 510(k) pathway after a 120-day FDA review.

K102884 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
120d
Days
Class 2
Risk

K102884 is an FDA 510(k) clearance for the STERRAD CYCLESURE 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 January 28, 2011 after a review of 120 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K102884

510(k) Number K102884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date January 28, 2011
Days to Decision 120 days
Submission Type Traditional
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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 169
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K102884.
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
K103321 · Dana Products, Inc. · Feb 2011
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
K101910 · 3M Company · Dec 2010
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · STERIS Corporation · Dec 2009
VERIFY SCBI 275F 3-10
K083665 · STERIS Corporation · Sep 2009