Cleared Special

K122362 - SMART-WELL INCUBATOR

K122362 is the FDA 510(k) clearance for SMART-WELL INCUBATOR by Mesa Laboratories, Inc.. It is a Class 2 General Hospital device (product code FRC) cleared through the Special 510(k) pathway after a 232-day FDA review.

K122362 · Mesa Laboratories, Inc. · General Hospital
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Mar 2013
Decision
232d
Days
Class 2
Risk

K122362 is an FDA 510(k) clearance for the SMART-WELL INCUBATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mesa Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 26, 2013 after a review of 232 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mesa Laboratories, Inc. devices

Submission Details

510(k) Number K122362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date March 26, 2013
Days to Decision 232 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

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.

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