Cleared Traditional

K170574 - Diacap Pro Dialyzer

K170574 is an FDA 510(k) clearance for Diacap Pro 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 165-day FDA review.

K170574 · B. Braun Avitum AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
165d
Days
Class 2
Risk

K170574 is an FDA 510(k) clearance for the Diacap Pro 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 August 11, 2017 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all B. Braun Avitum AG devices

FDA 510(k) Submission Details - K170574

510(k) Number K170574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date August 11, 2017
Days to Decision 165 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
35d slower than avg
Panel avg: 130d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K170574.
2008T BlueStar Hemodialysis Machine
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Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
NxStage System One
K171331 · Nxstage Medical, Inc. · Aug 2017
NxStage System One Plus
K170469 · Nxstage Medical, Inc. · May 2017
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017
Optiflux dialyzer
K162488 · Fresenius Medical Care North America · Apr 2017