Cleared Special

K053286 - MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

K053286 is an FDA 510(k) clearance for MODIFICATION TO: NXSTAGE PUREFLOW-B SOL..., 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 27-day FDA review.

K053286 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
27d
Days
Class 2
Risk

K053286 is an FDA 510(k) clearance for the MODIFICATION TO: NXSTAGE PUREFLOW-B 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 December 22, 2005 after a review of 27 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 - K053286

510(k) Number K053286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date December 22, 2005
Days to Decision 27 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
104d faster than avg
Panel avg: 131d · This submission: 27d
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 K053286.
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ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
K062399 · Rockwell Medical Technologies, Inc. · Nov 2006
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K050827 · Dialysis Solutions, Inc. · Aug 2005