Cleared Traditional

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS (K943654) - FDA 510(k) Clearance

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

K943654 · Mdt Biologic Co. · General Hospital
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Aug 1995
Decision
370d
Days
Class 2
Risk

K943654 is an FDA 510(k) clearance for the HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Mdt Biologic Co. (Rancho Dominguez, US). The FDA issued a Cleared decision on August 2, 1995 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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 Mdt Biologic Co. devices

Submission Details

510(k) Number K943654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date August 02, 1995
Days to Decision 370 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 129d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLR Sterilizer, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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.