Cleared Traditional

K091950 - SMART-WELL EZTEST INCUBATOR

K091950 is an FDA 510(k) clearance for SMART-WELL EZTEST INCUBATOR, manufactured by Sgm Biotech, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K091950 · Sgm Biotech, Inc. · General Hospital
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Jan 2010
Decision
198d
Days
Class 2
Risk

K091950 is an FDA 510(k) clearance for the SMART-WELL EZTEST INCUBATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Sgm Biotech, Inc. (Bozeman, US). The FDA issued a Cleared decision on January 15, 2010 after a review of 198 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 Sgm Biotech, Inc. devices

FDA 510(k) Submission Details - K091950

510(k) Number K091950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date January 15, 2010
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
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 154
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