Cleared Traditional

K012029 - REMEDY MODEL 2Z12

K012029 is an FDA 510(k) clearance for REMEDY MODEL 2Z12, manufactured by Apollo Corp.. The device is a Class 2 General Hospital device with product code KMG cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K012029 · Apollo Corp. · General Hospital
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Dec 2001
Decision
186d
Days
Class 2
Risk

K012029 is an FDA 510(k) clearance for the REMEDY MODEL 2Z12. Classified as Purifier, Water, Ultraviolet, Medical (product code KMG), Class II - Special Controls.

Submitted by Apollo Corp. (Somerset, US). The FDA issued a Cleared decision on December 31, 2001 after a review of 186 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6710 - 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 Apollo Corp. devices

FDA 510(k) Submission Details - K012029

510(k) Number K012029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date December 31, 2001
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMG Device Classification - Class 2, Special Controls

Product Code KMG Purifier, Water, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6710
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.