Cleared Traditional

K952660 - BRAUN HEMODIALYSIS CATHETER

K952660 is an FDA 510(k) clearance for BRAUN HEMODIALYSIS CATHETER, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 463-day FDA review.

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

FDA 510(k) Submission Details - K952660

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 131d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K952660.
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