Cleared Special

K150472 - NxStage System One (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150472 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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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.

View all Nxstage Medical, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.