Cleared Traditional

K140708 - VERIFY V24 SELF-CONTAINED BIOLOGICAL IN...

K140708 is the FDA 510(k) clearance for VERIFY V24 SELF-CONTAINED BIOLOGICAL IN... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K140708 · STERIS Corporation · General Hospital
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Jun 2014
Decision
87d
Days
Class 2
Risk

K140708 is an FDA 510(k) clearance for the VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR. 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 June 16, 2014 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all STERIS Corporation devices

Submission Details

510(k) Number K140708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date June 16, 2014
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 89
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