Cleared Traditional

DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS (K071518) - FDA 510(k) Clearance

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

K071518 · B. Braun Medizintechnologie GmbH · Gastroenterology & Urology device
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Aug 2007
Decision
74d
Days
Class 2
Risk

K071518 is an FDA 510(k) clearance for the DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by B. Braun Medizintechnologie GmbH (Melsungen, DE). The FDA issued a Cleared decision on August 17, 2007 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 B. Braun Medizintechnologie GmbH devices

Submission Details

510(k) Number K071518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date August 17, 2007
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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.

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