Cleared Traditional

K043436 - NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269

K043436 is an FDA 510(k) clearance for NXSTAGE DIALYSATE PREPARATION MODULE, 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 94-day FDA review.

K043436 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
94d
Days
Class 2
Risk

K043436 is an FDA 510(k) clearance for the NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269. 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 March 17, 2005 after a review of 94 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. 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 - K043436

510(k) Number K043436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date March 17, 2005
Days to Decision 94 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
36d faster than avg
Panel avg: 130d · This submission: 94d
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 K043436.
NXSTAGE PUREFLOW SL
K111174 · Nxstage Medical, Inc. · Sep 2011
NXSTAGE PUREFLOW SL
K080919 · Nxstage Medical, Inc. · Oct 2008
NXSTAGE DIALYSATE PREPARATION MODULE
K060296 · Nxstage Medical, Inc. · Mar 2006
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
K850756 · Travenol Laboratories, S.A. · Mar 1985
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · Trimedyne, Inc. · Jun 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · Gambro, Inc. · Feb 1981