Cleared Traditional

K152938 - DBB-06 Hemodialysis Delivery System

K152938 is an FDA 510(k) clearance for DBB-06 Hemodialysis Delivery System, manufactured by NIKKISO CO., LTD.. 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.

K152938 · NIKKISO CO., LTD. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
165d
Days
Class 2
Risk

K152938 is an FDA 510(k) clearance for the DBB-06 Hemodialysis Delivery System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by NIKKISO CO., LTD. (Shibuya-Ku, JP). The FDA issued a Cleared decision on March 18, 2016 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 NIKKISO CO., LTD. devices

FDA 510(k) Submission Details - K152938

510(k) Number K152938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date March 18, 2016
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. 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 Consultant

Mic International
FUMIAKI KANAI

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.

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

All 320
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K152938.
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