Cleared Traditional

ALDAHOL V HIGH LEVEL DISINFECTANT (K113015) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113015 · Microchem Laboratories, Inc. · General Hospital
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Jan 2012
Decision
111d
Days
Class 2
Risk

K113015 is an FDA 510(k) clearance for the ALDAHOL V HIGH LEVEL DISINFECTANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Microchem Laboratories, Inc. (Euless, US). The FDA issued a Cleared decision on January 30, 2012 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Microchem Laboratories, Inc. devices

Submission Details

510(k) Number K113015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date January 30, 2012
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 63
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