Cleared Traditional

K073618 - VERIFY SIRIUS BIOLOGICAL INDICATOR CHAL...

K073618 is the FDA 510(k) clearance for VERIFY SIRIUS BIOLOGICAL INDICATOR CHAL... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K073618 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
378d
Days
Class 2
Risk

K073618 is an FDA 510(k) clearance for the VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK. 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 January 7, 2009 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K073618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date January 07, 2009
Days to Decision 378 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
249d slower than avg
Panel avg: 129d · This submission: 378d
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 114
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K073618.
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
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
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · Advanced Sterilization Products · May 2007