Cleared Traditional

K141752 - NXSTAGE SYSTEM ONE

K141752 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 Traditional 510(k) pathway after a 172-day FDA review.

K141752 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Dec 2014
Decision
172d
Days
Class 2
Risk

K141752 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 December 19, 2014 after a review of 172 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 - K141752

510(k) Number K141752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2014
Decision Date December 19, 2014
Days to Decision 172 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
42d slower than avg
Panel avg: 130d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00667511 Completed Interventional

Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™

58
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Kidney Failure, Chronic; End-Stage Renal Disease
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Paul Kravitz
Sponsor NxStage Medical
Started 2008-04-01 → Primary completion 2014-05-01
Primary outcome
Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
View full study on ClinicalTrials.gov