Cleared Traditional

K103832 - PHOENIX HEMODIALYSIS DELIVERY SYSTEM

K103832 is an FDA 510(k) clearance for PHOENIX HEMODIALYSIS DELIVERY SYSTEM, manufactured by Gambro Renal Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K103832 · Gambro Renal Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
141d
Days
Class 2
Risk

K103832 is an FDA 510(k) clearance for the PHOENIX HEMODIALYSIS DELIVERY SYSTEM. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro Renal Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Gambro Renal Products, Inc. devices

FDA 510(k) Submission Details - K103832

510(k) Number K103832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date May 20, 2011
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 315
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K103832.
FRESENIUS 2008T HEMODIALYSIS MACHINE
K113427 · Fresenius Medical Care North America · Dec 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K111639 · Fresenius Medical Care · Oct 2011
PRISMAFLEX
K110823 · Gambro Renal Products, Inc. · Jun 2011
VENOFER PUMP
K103564 · Renal Solutions, Inc. · Feb 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
K101715 · Fresenius Medical Care North America, Design Cente · Dec 2010
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
K093069 · Nxstage Medical, Inc. · Oct 2010