Cleared Traditional

K080919 - NXSTAGE PUREFLOW SL

K080919 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 Traditional 510(k) pathway after a 197-day FDA review.

K080919 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
197d
Days
Class 2
Risk

K080919 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 October 15, 2008 after a review of 197 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 - K080919

510(k) Number K080919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date October 15, 2008
Days to Decision 197 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K080919.
NXSTAGE PUREFLOW SL
K140571 · Nxstage Medical, Inc. · May 2014
NXSTAGE PUREFLOW SL
K111174 · Nxstage Medical, Inc. · Sep 2011
NXSTAGE DIALYSATE PREPARATION MODULE
K060296 · Nxstage Medical, Inc. · Mar 2006
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
K043436 · Nxstage Medical, Inc. · Mar 2005
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
K850756 · Travenol Laboratories, S.A. · Mar 1985
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · Trimedyne, Inc. · Jun 1981