Cleared Traditional

5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K041791) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041791 · Chf Solutions, Inc. · Gastroenterology & Urology device
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Sep 2004
Decision
70d
Days
Class 2
Risk

K041791 is an FDA 510(k) clearance for the 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC). Classified as Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use (product code NQJ), Class II - Special Controls.

Submitted by Chf Solutions, Inc. (Brooklyn Park Mn, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Chf Solutions, Inc. devices

Submission Details

510(k) Number K041791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2004
Decision Date September 10, 2004
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQJ Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition Dual Lumen, Non-implanted, Peripheral Access Catheters Are Inserted In The Peripheral Arm Vein And Are Indicated For Temporary (up To 8 Hours) Ultrafiltration Treatment Of Patients With Fluid Overload.
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.