Cleared Special

K033386 - NXSTAGE PUREFLOW SOLUTION

K033386 is an FDA 510(k) clearance for NXSTAGE PUREFLOW SOLUTION, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Special 510(k) pathway after a 34-day FDA review.

K033386 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
34d
Days
Class 2
Risk

K033386 is an FDA 510(k) clearance for the NXSTAGE PUREFLOW SOLUTION. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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. Low regulatory complexity profile. 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 - K033386

510(k) Number K033386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date November 26, 2003
Days to Decision 34 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
97d faster than avg
Panel avg: 131d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 95
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K033386.
B. BRAUN BICARBONATE DIALYSATE
K041683 · B.Braun Medical, Inc. · Aug 2004
NXSTAGE PUREFLOW-B SOLUTION
K042045 · Nxstage Medical, Inc. · Aug 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · B.Braun Medical, Inc. · Mar 2004
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
K030497 · Fresenius Medical Care · May 2003
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
K023985 · Rockwell Medical Technologies, Inc. · Feb 2003
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
K022521 · Rockwell Medical Technologies, Inc. · Jan 2003