Cleared Traditional

K182940 - Surdial DX Hemodialysis System

K182940 is the FDA 510(k) clearance for Surdial DX Hemodialysis System by Nipro Medical Corporation. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K182940 · Nipro Medical Corporation · Gastroenterology & Urology device
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Jul 2019
Decision
269d
Days
Class 2
Risk

K182940 is an FDA 510(k) clearance for the Surdial DX Hemodialysis System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on July 19, 2019 after a review of 269 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 Nipro Medical Corporation devices

Submission Details

510(k) Number K182940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2018
Decision Date July 19, 2019
Days to Decision 269 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
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K182940.
Tablo Hemodialysis System, Tablo Cartridge
K190793 · Outset Medical, Inc. · Dec 2019
NxStage Cartridge Express with Speedswap
K183158 · Nxstage Medical, Inc. · Aug 2019
PrisMax System Version 2
K190910 · Baxter Healthcare Corp · Jul 2019
2008T BlueStar Hemodialysis Machine
K173972 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
NxStage System One
K171331 · Nxstage Medical, Inc. · Aug 2017