Cleared Special

K150472 - NxStage System One

K150472 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 ODN cleared through the Special 510(k) pathway after a 101-day FDA review.

K150472 · 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 2015
Decision
101d
Days
Class 2
Risk

K150472 is an FDA 510(k) clearance for the NxStage System One. Classified as Ultrafiltration-controlled Nocturnal Dialysate Delivery System (product code ODN), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on June 4, 2015 after a review of 101 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150472

510(k) Number K150472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date June 04, 2015
Days to Decision 101 days
Submission Type Special
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
30d faster than avg
Panel avg: 131d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

ODN Device Classification - Class 2, Special Controls

Product Code ODN Ultrafiltration-controlled Nocturnal Dialysate Delivery System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
Definition Hemodialysis Performed With A High Permeability Hemodialyzer And An Ultrafiltration-controlled System. Nocturnal Hemodialysis For Patients With End-stage Renal Disease (chronic Dialysis) Or Acute Renal Failure (acute Dialysis) Performed With A High Permeability Hemodialyzer And An Ultrafiltration-controlled System.
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.