Cleared Traditional

K162248 - Asahi ViE-U Series Dialyzer

K162248 is an FDA 510(k) clearance for Asahi ViE-U Series Dialyzer, manufactured by Asahi Kasei Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K162248 · Asahi Kasei Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
266d
Days
Class 2
Risk

K162248 is an FDA 510(k) clearance for the Asahi ViE-U Series Dialyzer. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Asahi Kasei Medical Co., Ltd. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on May 3, 2017 after a review of 266 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 Asahi Kasei Medical Co., Ltd. devices

FDA 510(k) Submission Details - K162248

510(k) Number K162248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2016
Decision Date May 03, 2017
Days to Decision 266 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
135d slower than avg
Panel avg: 131d · This submission: 266d
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

Boston Biomedical Associates
Megan Shackelford

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
NCT02292212 Completed Interventional Industry-sponsored

Clinical Study of Asahi ViE Dialyzer in Canada

Clinical Study of Asahi ViE Dialyzer in Canada (AVID)

17
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Kidney Failure, Chronic
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Mercedeh Kiaii, MD
Sponsor Asahi Kasei Medical Co., Ltd. (industry)
Started 2014-11-24 → Primary completion 2015-11-06
Primary outcome
Removal Rate of Urea
Secondary outcome
Device Malfunctions
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 K162248.
NxStage System One
K171331 · Nxstage Medical, Inc. · Aug 2017
Diacap Pro Dialyzer
K170574 · B. Braun Avitum AG · 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
FB-U Hemodialyzer
K160444 · Nipro Medical Corporation · Feb 2017