Cleared Traditional

K112018 - SMART READ EZTEST STEAM

K112018 is the FDA 510(k) clearance for SMART READ EZTEST STEAM by Mesa Laboratories, Inc.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K112018 · Mesa Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
200d
Days
Class 2
Risk

K112018 is an FDA 510(k) clearance for the SMART READ EZTEST STEAM. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mesa Laboratories, Inc. (Bozeman, US). The FDA issued a Cleared decision on January 30, 2012 after a review of 200 days - an extended review 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: 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 Mesa Laboratories, Inc. devices

Submission Details

510(k) Number K112018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2011
Decision Date January 30, 2012
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
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 115
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K112018.
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
K122044 · Advanced Sterilization Products · Oct 2012
STERRAD (R) 100NX DUO CYCLE TEST PACK
K111391 · Advanced Sterilization Products · Sep 2012
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
K111375 · Advanced Sterilization Products · Sep 2012
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011