Cleared Traditional

K050525 - NXSTAGE SYSTEM ONE

K050525 is an FDA 510(k) clearance for NXSTAGE SYSTEM ONE, 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 114-day FDA review.

K050525 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
114d
Days
Class 2
Risk

K050525 is an FDA 510(k) clearance for the NXSTAGE SYSTEM ONE. 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 June 24, 2005 after a review of 114 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K050525

510(k) Number K050525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date June 24, 2005
Days to Decision 114 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
17d faster than avg
Panel avg: 131d · This submission: 114d
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 333
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K050525.
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · Minntech Corp. · Jan 2006
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
K051520 · Gambro Renal Products · Dec 2005
AQUADEX SYSTEM
K050609 · Chf Solutions, Inc. · Nov 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
K050727 · Nxstage Medical, Inc. · Jun 2005
OLPUR DIALYZER, MODEL HD 190
K050603 · Nephros, Inc. · Jun 2005
REXEED SERIES DIALYZERS
K051187 · Asahi Kasei Medical Co., Ltd. · Jun 2005