Cleared Traditional

K073618 - VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK

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

K073618 · STERIS Corporation · General Hospital
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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

FDA 510(k) Submission Details - K073618

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.

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 180
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
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
K070595 · Spsmedical Supply Corp. · May 2007