Cleared Traditional

OZONE GENERATOR (K043207) - FDA 510(k) Clearance

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

K043207 · Ge Infrastructure Water & Process Technologies · General Hospital
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Nov 2005
Decision
350d
Days
Class 2
Risk

K043207 is an FDA 510(k) clearance for the OZONE GENERATOR. Classified as Disinfectant, Dialysate Delivery System (product code NII), Class II - Special Controls.

Submitted by Ge Infrastructure Water & Process Technologies (Minnetonka, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.5860 - 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 Ge Infrastructure Water & Process Technologies devices

Submission Details

510(k) Number K043207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date November 04, 2005
Days to Decision 350 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
221d slower than avg
Panel avg: 129d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NII Disinfectant, Dialysate Delivery System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
Definition Disinfectant Intended For Reprocessing Dialysate Delivery Systems.
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.