Cleared Traditional

K092906 - VERIFY BIOLOGICAL INDICATOR CHALLENGE P...

K092906 is the FDA 510(k) clearance for VERIFY BIOLOGICAL INDICATOR CHALLENGE P... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K092906 · STERIS Corporation · General Hospital
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Dec 2009
Decision
100d
Days
Class 2
Risk

K092906 is an FDA 510(k) clearance for the VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 30, 2009 after a review of 100 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 STERIS Corporation devices

Submission Details

510(k) Number K092906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date December 30, 2009
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 110
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K092906.
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
K101910 · 3M Company · Dec 2010
VERIFY SCBI 275F 3-10
K083665 · STERIS Corporation · Sep 2009
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
K090569 · 3M Company · Apr 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES
K090514 · STERIS Corporation · Mar 2009