Cleared Traditional

K013655 - NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

K013655 is an FDA 510(k) clearance for NXSTAGE DIALYSATE CONCENTRATE, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013655 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
90d
Days
Class 2
Risk

K013655 is an FDA 510(k) clearance for the NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100. 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 February 4, 2002 after a review of 90 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 - K013655

510(k) Number K013655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date February 04, 2002
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 59
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K013655.
B.BRAUN PREMIXED DIALYSATE
K034066 · B.Braun Medical, Inc. · Mar 2004
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc. · Nov 2003
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc. · Oct 2002
PRISMASATE
K013448 · Gambro Renal Products · Jan 2002
BICART
K013724 · Gambro Renal Products · Jan 2002
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · Gambro Renal Products · Aug 2001