Cleared Traditional

K140589 - STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR

K140589 is an FDA 510(k) clearance for STERRAD CYCLESURE 24 PLUS BIOLOGICAL IN..., manufactured by Mesa Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K140589 · Mesa Laboratories, Inc. · General Hospital
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Dec 2014
Decision
271d
Days
Class 2
Risk

K140589 is an FDA 510(k) clearance for the STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mesa Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on December 3, 2014 after a review of 271 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

FDA 510(k) Submission Details - K140589

510(k) Number K140589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date December 03, 2014
Days to Decision 271 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 129d · This submission: 271d
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 181
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K140589.
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K141238 · Sterilucent, Inc. · Nov 2014
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K141312 · Sterilucent, Inc. · Oct 2014
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
K141244 · North American Science Assoc., Inc. · Sep 2014