Cleared Traditional

K143482 - xevonta dialyzer

K143482 is an FDA 510(k) clearance for xevonta dialyzer, manufactured by B. Braun Avitum AG. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K143482 · B. Braun Avitum AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
449d
Days
Class 2
Risk

K143482 is an FDA 510(k) clearance for the xevonta dialyzer. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by B. Braun Avitum AG (Melsungen, DE). The FDA issued a Cleared decision on March 1, 2016 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: 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 Avitum AG devices

FDA 510(k) Submission Details - K143482

510(k) Number K143482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date March 01, 2016
Days to Decision 449 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
318d slower than avg
Panel avg: 131d · This submission: 449d
Pathway characteristics
Predicate-based equivalence.

KDI Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

B.Braun Medical, Inc.
Tracy Maddock

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01111266 Completed Interventional Industry-sponsored

Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)

Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD

12
Patients (actual)
1
Site
Basic_science
Purpose
Open label
Masking
Condition studied Kidney Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jürgen Wagner, Prof. Dr.
Sponsor B.Braun Avitum AG (industry)
Started 2010-03-01 → Primary completion 2011-08-01 → Completed 2012-03-01
Primary outcome
in vivo KUF
Secondary outcome
Determination of removal rates
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 315
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K143482.
Tablo Console
K160881 · Outset Medical, Inc. · Nov 2016
2008K2 Hemodialysis Machine
K153449 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2016
DBB-06 Hemodialysis Delivery System
K152938 · NIKKISO CO., LTD. · Mar 2016
Asahi REXEED-S Series Dialyzer
K153344 · Asahi Kasei Medical Co., Ltd. · Dec 2015
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
K150708 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2015
Optiflux dialyzer
K152367 · Fresenius Medical Care North America · Oct 2015