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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 131d · This submission: 165d
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
NCT02964429 Completed Interventional Industry-sponsored

Determination In-vivo KUF for Diacap Pro Hemodialyser

Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis

12
Patients (actual)
1
Site
Basic_science
Purpose
Open label
Masking
Condition studied Kidney Failure,Chronic; Renal Insufficiency,Chronic; Kidney Disease, End-Stage; Kidney Insufficiency
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Vladimir Polakovic, Prim. MUDr.
Sponsor B.Braun Avitum AG (industry)
Started 2016-11-14 → Primary completion 2016-12-23
Primary outcome
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
Secondary outcome
Clearance data dialyzer [ml/min]
Study completed - no results published. This trial concluded in 2016 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. Individual participant data will not be shared.
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 K170574.
Prismaflex System 8.10
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NxStage System One
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NxStage System One Plus
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K162248 · Asahi Kasei Medical Co., Ltd. · May 2017
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017