Cleared Special

K090514 - VERIFY SELF-CONTAINED BIOLOGICAL INDICA...

K090514 is the FDA 510(k) clearance for VERIFY SELF-CONTAINED BIOLOGICAL INDICA... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Special 510(k) pathway after a 18-day FDA review.

K090514 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
18d
Days
Class 2
Risk

K090514 is an FDA 510(k) clearance for the VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATIO.... 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 March 16, 2009 after a review of 18 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 STERIS Corporation devices

Submission Details

510(k) Number K090514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date March 16, 2009
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 110
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K090514.
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · STERIS Corporation · Dec 2009
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 SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
K073618 · STERIS Corporation · Jan 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES
K073244 · STERIS Corporation · May 2008
STERRAD 100NX TEST PACK
K071537 · Advanced Sterilization Products · Dec 2007