Cleared Traditional

BRAUN HEMODIALYSIS CATHETER (K952660) - FDA 510(k) Clearance

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

K952660 · B.Braun Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
463d
Days
Class 2
Risk

K952660 is an FDA 510(k) clearance for the BRAUN HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (So. San Francisco, US). The FDA issued a Cleared decision on September 17, 1996 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K952660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date September 17, 1996
Days to Decision 463 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
333d slower than avg
Panel avg: 130d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPB Catheter, Hemodialysis, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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.

Regulatory Peers - MPB Catheter, Hemodialysis, Non-implanted

All 37
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K952660.
14F Duo-Flow® Side X Side Double Lumen Catheter
K250836 · Medical Components, Inc. · Aug 2025
Acute Dual Lumen Hemodialysis Catheter
K200426 · Health Line International Corporation · Dec 2020
Duo-Flow Side x Side Double Lumen Catheter
K192807 · Medical Components, Inc. (dba MedComp) · Apr 2020
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
K192302 · Covidien, LLC · Jan 2020
Zenysis Short-Term Dialysis Catheter
K163458 · C.R. Bard, Inc. · Apr 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K161504 · Cook Incorporated · Jan 2017