Cleared Traditional

HT-WEDGE (K121287) - FDA 510(k) Clearance

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

K121287 · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · General Hospital
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Oct 2012
Decision
156d
Days
Class 2
Risk

K121287 is an FDA 510(k) clearance for the HT-WEDGE. Classified as Lift, Patient, Ac-powered (product code FNG), Class II - Special Controls.

Submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (Bethlehem, US). The FDA issued a Cleared decision on October 3, 2012 after a review of 156 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5500 - 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 D.T. Davis Enterprises Ltd. T/A Hovertech Int'L devices

Submission Details

510(k) Number K121287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date October 03, 2012
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNG Lift, Patient, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5500
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.