Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device Code: 1945

Product Code(s): KDI

Device Classification Information

Device Type ID1945
Device NameDialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation DescriptionHigh Permeability Hemodialysis System.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type510(k)
CFR Regulation Number876.5860 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKDI
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1945
DeviceDialyzer, High Permeability With Or Without Sealed Dialysate System
Product CodeKDI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHigh Permeability Hemodialysis System.
CFR Regulation Number876.5860 [🔎]
Premarket Reviews
ManufacturerDecision
ASAHI
 
SUBSTANTIALLY EQUIVALENT
 2
ASAHI KASEI MEDICAL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
B. BRAUN AVITUM AG
 
SUBSTANTIALLY EQUIVALENT
 2
BAXTER HEALTHCARE CORP
 
SUBSTANTIALLY EQUIVALENT
 1
BAXTER HEALTHCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
BAXTER HEALTHCARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
BELLCO SRL
 
SUBSTANTIALLY EQUIVALENT
 1
FRESENIUS
 
SUBSTANTIALLY EQUIVALENT
 3
FRESENIUS MEDICAL CARE NORTH AMERICA
 
SUBSTANTIALLY EQUIVALENT
 3
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
GAMBRO
 
SUBSTANTIALLY EQUIVALENT
 1
GAMBRO RENAL PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
HOME DIALYSIS PLUS
 
SUBSTANTIALLY EQUIVALENT
 1
NIPRO CORP
 
SUBSTANTIALLY EQUIVALENT
 2
NIPRO CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
NXSTAGE MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 6
NXSTAGE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
OUTSET MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SPECTRAL MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Insufficient Information
 1721
Fluid Leak
 1126
Device Operates Differently Than Expected
 999
Reflux Within Device
 928
Mechanical Problem
 927
Adverse Event Without Identified Device Or Use Problem
 600
Thermal Decomposition Of Device
 473
Absorber
 301
Leak / Splash
 279
Inadequate Ultra Filtration
 259
Product Quality Problem
 197
Melted
 127
Crack
 126
Detachment Of Device Or Device Component
 90
Cap
 86
Disconnection
 79
Smoking
 70
Device Contamination With Chemical Or Other Material
 68
Charred
 54
Connection Problem
 51
Break
 37
Device Displays Incorrect Message
29
Sparking
 28
Improper Or Incorrect Procedure Or Method
 25
Connector
 24
Pressure Problem
 24
Complete Blockage
 20
Fiber
 19
Loose Or Intermittent Connection
 19
Coagulation In Device Or Device Ingredient
 19
Misassembled
 19
Detachment Of Device Component
 18
Pumping Stopped
 16
Device Alarm System
 15
Pumping Problem
 15
Air Leak
 14
Component Missing
14
Use Of Device Problem
 12
Contamination During Use
 12
Appropriate Term/Code Not Available
 11
Overheating Of Device
 11
Calibration Problem
 11
Tube
 10
Patient-Device Incompatibility
 10
Fire
 10
No Apparent Adverse Event
 9
Hole In Material
 9
Improper Flow Or Infusion
 9
Filling Problem
 9
Failure To Disconnect
 9
Filtration Problem
 8
Device Handling Problem
 8
Port
 8
Misassembly By Users
 7
Device Issue
 7
Failure To Infuse
 7
Biocompatibility
7
Seal
 6
No Audible Alarm
 5
No Flow
 5
Obstruction Of Flow
 5
Material Integrity Problem
 5
Fracture
 5
Defective Alarm
 5
Imprecision
5
Cut In Material
 5
Alarm Not Visible
5
Partial Blockage
 5
Arcing
 4
Off-Label Use
 4
Material Separation
 4
Filter
 4
Housing
 4
Calibration Error
 4
Device Reprocessing Problem
 4
Infusion Or Flow Problem
 4
Material Discolored
 4
Misconnection
 4
Occlusion Within Device
 4
Backflow
 4
Electrical /Electronic Property Problem
 3
Bags
 3
Device Inoperable
 3
Defective Component
 3
Corroded
3
Power Problem
 3
Bent
 3
No Audible Prompt / Feedback
3
Split
 3
Temperature Problem
 3
Electrical Shorting
 3
Material Deformation
 2
Inadequate Filtration Process
 2
Use Of Incorrect Control Settings
 2
Failure To Power Up
 2
Membrane
 2
Material Rupture
 2
Component Falling
 2
Failure To Sense
2
Migration Or Expulsion Of Device
2
Total Device Problems 9255
Recalls
Manufacturer Recall Class Date Posted
1
B Braun Medical Inc
 I May-03-2016
2
Baxter Healthcare Corp.
 II Mar-13-2015
3
Baxter Healthcare Corp.
 II Jul-17-2014
4
Baxter Healthcare Corp.
 II Jun-30-2014
5
Baxter Healthcare Corporation
 II May-23-2018
6
Baxter Healthcare Corporation
 II Mar-30-2018
7
Baxter Healthcare Corporation
 II Jan-25-2017
8
Fresenius Medical Care Holdings, Inc.
 II Apr-29-2015
9
Fresenius Medical Care Holdings, Inc.
 II Jan-27-2015
10
Fresenius Medical Care Holdings, Inc.
 II May-13-2014
11
Fresenius Medical Care Holdings, Inc.
 II Feb-26-2014
12
Fresenius Medical Care Holdings, Inc.
 II Feb-03-2014
13
Fresenius Medical Care Holdings, Inc.
 II Jan-06-2014
14
Fresenius Medical Care Renal Therapies Group, LLC
 II Dec-21-2018
15
Fresenius Medical Care Renal Therapies Group, LLC
 II Sep-19-2018
16
Fresenius Medical Care Renal Therapies Group, LLC
 II Mar-20-2018
17
Fresenius Medical Care Renal Therapies Group, LLC
 II Feb-20-2018
18
Fresenius Medical Care Renal Therapies Group, LLC
 II Jan-13-2017
19
Fresenius Medical Care Renal Therapies Group, LLC
 II Apr-05-2016
20
Gambro Renal Products Inc
 II Dec-01-2014
21
Gambro Renal Products, Incorporated
 II Aug-13-2014
22
Gambro Renal Products, Incorporated
 II May-21-2014
23
Medivators, Inc.
 II Sep-11-2015
24
Medtronic Perfusion Systems
 II Sep-04-2015
25
NxStage Medical, Inc.
 II Aug-14-2018
26
NxStage Medical, Inc.
 II Nov-25-2015
27
NxStage Medical, Inc.
 II Nov-23-2015
TPLC Last Update: 2019-04-02 20:02:26
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