Cleared Traditional

K083158 - EXALIS, SOFTWARE VERSION 1.15

K083158 is an FDA 510(k) clearance for EXALIS, 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 224-day FDA review.

K083158 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
224d
Days
Class 2
Risk

K083158 is an FDA 510(k) clearance for the EXALIS, SOFTWARE VERSION 1.15. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Denver, US). The FDA issued a Cleared decision on June 5, 2009 after a review of 224 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 - K083158

510(k) Number K083158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2008
Decision Date June 05, 2009
Days to Decision 224 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
93d slower than avg
Panel avg: 131d · This submission: 224d
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 K083158.
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170
K093120 · Baxter Healthcare Corporation - Renal Division · Feb 2010
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
K093379 · Bl Healthcare, Inc. · Feb 2010
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
K090682 · Edwards Lifesciences Services GmbH · Nov 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · Baxter Healthcare Corporation · Feb 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · Fresenius Medical Care North America · Jan 2009
OMNI-DL SYSTEM
K080650 · Transvivo, Inc. · Nov 2008