Cleared Traditional

K143313 - NxStage Therapeutic Plasma Exchange (TPE) Cartridge

K143313 is an FDA 510(k) clearance for NxStage Therapeutic Plasma Exchange (TP..., 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 121-day FDA review.

K143313 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
121d
Days
Class 2
Risk

K143313 is an FDA 510(k) clearance for the NxStage Therapeutic Plasma Exchange (TPE) Cartridge. 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 March 20, 2015 after a review of 121 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.

View all Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K143313

510(k) Number K143313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date March 20, 2015
Days to Decision 121 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
9d faster than avg
Panel avg: 130d · This submission: 121d
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 246
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K143313.
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Optiflux dialyzer
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NXSTAGE SYSTEM ONE
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ELISIO-H HEMODIALYZER
K140191 · Nipro Medical Corporation · Apr 2014
NXSTAGE SYSTEM ONE WITH NXVIEW
K133547 · Nxstage Medical, Inc. · Mar 2014