Cleared Traditional

K131050 - NXSTAGE 1.6M2 DIALYZER

K131050 is an FDA 510(k) clearance for NXSTAGE 1.6M2 DIALYZER, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K131050 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Dec 2013
Decision
256d
Days
Class 2
Risk

K131050 is an FDA 510(k) clearance for the NXSTAGE 1.6M2 DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on December 27, 2013 after a review of 256 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 Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K131050

510(k) Number K131050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2013
Decision Date December 27, 2013
Days to Decision 256 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
126d slower than avg
Panel avg: 130d · This submission: 256d
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 246
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K131050.
NXSTAGE SYSTEM ONE WITH NXVIEW
K133547 · Nxstage Medical, Inc. · Mar 2014
STREAMLINE EXPRESS
K132602 · Nxstage Medical, Inc. · Feb 2014
OPTIFLUX ULTRA DIALYZER
K123262 · Fresenius Medical Care North America · Jan 2014
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · Nipro Medical Corporation · Dec 2013
ELISIO-H HEMODIALYZER
K131381 · Nipro Medical Corporation · Dec 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · Fresenius Medical Care Renal Therapies Group, LLC · Oct 2013