Cleared Traditional

K233515 - Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (FDA 510(k) Clearance)

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

K233515 · Nuwellis, Inc. · Gastroenterology & Urology device
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Dec 2023
Decision
55d
Days
Class 2
Risk

K233515 is an FDA 510(k) clearance for the Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Ex.... Classified as Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use (product code NQJ), Class II - Special Controls.

Submitted by Nuwellis, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 26, 2023 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 876.5540 - 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 Nuwellis, Inc. devices

Submission Details

510(k) Number K233515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2023
Decision Date December 26, 2023
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
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.