Cleared Special

K111174 - NXSTAGE PUREFLOW SL

K111174 is an FDA 510(k) clearance for NXSTAGE PUREFLOW SL, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKR cleared through the Special 510(k) pathway after a 145-day FDA review.

K111174 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
145d
Days
Class 2
Risk

K111174 is an FDA 510(k) clearance for the NXSTAGE PUREFLOW SL. Classified as Subsystem, Proportioning (product code FKR), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on September 19, 2011 after a review of 145 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K111174

510(k) Number K111174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2011
Decision Date September 19, 2011
Days to Decision 145 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
14d slower than avg
Panel avg: 131d · This submission: 145d
Pathway characteristics
Modification to existing cleared device.

FKR Device Classification - Class 2, Special Controls

Product Code FKR Subsystem, Proportioning
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 - FKR Subsystem, Proportioning

All 10
Devices cleared under the same product code (FKR) and FDA review panel - the closest regulatory comparables to K111174.
NXSTAGE PUREFLOW SL
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K850756 · Travenol Laboratories, S.A. · Mar 1985
CHEMATIC BICARBONATE DIALYSATE SYSTEM
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