Cleared Special

K082238 - NEOMED POLYURETHANE FEEDING TUBE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082238 · Neomed, Inc. · Gastroenterology & Urology device
Oct 2008
Decision
55d
Days
Class 2
Risk

K082238 is an FDA 510(k) clearance for the NEOMED POLYURETHANE FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on October 1, 2008 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K082238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2008
Decision Date October 01, 2008
Days to Decision 55 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 156d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPD Tube, Feeding
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.