Cleared Traditional

K070643 - PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

K070643 is an FDA 510(k) clearance for PHOENIX HEMODIALYSIS DELIVERY SYSTEM, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K070643 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
239d
Days
Class 2
Risk

K070643 is an FDA 510(k) clearance for the PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 239 days - an extended review cycle.

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, Inc. devices

FDA 510(k) Submission Details - K070643

510(k) Number K070643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2007
Decision Date November 02, 2007
Days to Decision 239 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
108d slower than avg
Panel avg: 131d · This submission: 239d
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 320
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K070643.
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
K082515 · Asahi Kasei Medical Co., Ltd. · Oct 2008
PRISMAFLEX M150 SET
K080519 · Gambro Renal Products, Inc. · Jun 2008
PRISMAFLEX SYSTEM, VERSION 3.20
K072093 · Gambro · Feb 2008
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K061519 · NIKKISO CO., LTD. · Sep 2007
AQUADEX FLEXFLOW SYSTEM
K071854 · Chf Solutions, Inc. · Sep 2007
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
K072232 · Gambro Renal Products, Inc. · Sep 2007