Cleared Traditional

K041424 - NXSTAGE SYSTEM ONE

K041424 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 35-day FDA review.

K041424 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
35d
Days
Class 2
Risk

K041424 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 July 2, 2004 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041424

510(k) Number K041424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date July 02, 2004
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
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 K041424.
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
K043244 · Fresenius Medical Care North America · Dec 2004
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
K041005 · Gambro Renal Products · Oct 2004
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
K041726 · Asahi Medical Co., Ltd. · Jul 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
K040255 · Gambro Renal Products, Inc. · May 2004
AQUADEX SYSTEM 100, MODEL A1100
K040489 · Chf Solutions, Inc. · Apr 2004