Cleared Traditional

K993042 - MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (FDA 510(k) Clearance)

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

K993042 · Medivators, Inc. · General Hospital
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Aug 2000
Decision
342d
Days
Class 2
Risk

K993042 is an FDA 510(k) clearance for the MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Medivators, Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medivators, Inc. devices

Submission Details

510(k) Number K993042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1999
Decision Date August 17, 2000
Days to Decision 342 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
214d slower than avg
Panel avg: 128d · This submission: 342d
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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