Cleared Traditional

K153384 - Low Potassium Dextran Solution with Tri...

K153384 is an FDA 510(k) clearance for Low Potassium Dextran Solution with Tri..., manufactured by United Therapeutics Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K153384 · United Therapeutics Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
88d
Days
Class 2
Risk

K153384 is an FDA 510(k) clearance for the Low Potassium Dextran Solution with Tris Diluent. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by United Therapeutics Corporation (Research Triangle Park, US). The FDA issued a Cleared decision on February 19, 2016 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United Therapeutics Corporation devices

FDA 510(k) Submission Details - K153384

510(k) Number K153384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date February 19, 2016
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDN Device Classification - Class 2, Special Controls

Product Code KDN System, Perfusion, Kidney
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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.