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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dialyzer, high permeability with or without sealed dialysate system
Regulation Description High permeability hemodialysis system.
Product CodeKDI
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DIALITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 11
MEDICA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
QUANTA DIALYSIS TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TECNOIDEAL AMERICA
  SUBSTANTIALLY EQUIVALENT 1
VANTIVE US HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1944 4392
2022 2180 2207
2023 2692 2695
2024 2441 2443
2025 2822 2822
2026 457 457

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8543 8794
Adverse Event Without Identified Device or Use Problem 984 2570
Break 616 616
Thermal Decomposition of Device 569 569
Crack 335 335
Inadequate Ultra Filtration 325 325
Device Contamination with Chemical or Other Material 218 218
Labelling, Instructions for Use or Training Problem 177 177
Leak/Splash 165 171
Air/Gas in Device 150 282
Obstruction of Flow 127 135
Melted 102 102
Detachment of Device or Device Component 99 99
Protective Measures Problem 95 95
Disconnection 91 91
Smoking 77 77
Calibration Problem 69 69
Improper or Incorrect Procedure or Method 66 188
No Apparent Adverse Event 64 64
Material Puncture/Hole 52 52
Device Alarm System 46 47
Loose or Intermittent Connection 42 52
Improper Flow or Infusion 37 37
Filtration Problem 35 35
Material Split, Cut or Torn 33 33
Mechanical Problem 33 33
Therapeutic or Diagnostic Output Failure 31 160
Use of Device Problem 29 29
Sparking 28 28
Patient-Device Incompatibility 28 150
Unexpected Shutdown 26 27
Infusion or Flow Problem 26 26
No Audible Alarm 26 26
Material Rupture 23 145
Insufficient Information 23 145
Output Problem 22 22
Fire 22 22
Pressure Problem 22 32
Filling Problem 21 21
Reflux within Device 21 21
Biocompatibility 20 20
Defective Device 19 19
Connection Problem 18 18
Device Displays Incorrect Message 16 18
Display or Visual Feedback Problem 16 16
No Display/Image 16 17
Defective Component 15 27
Product Quality Problem 14 25
Priming Problem 13 13
Defective Alarm 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7463 7470
Hemorrhage/Bleeding 3389 4001
Hypersensitivity/Allergic reaction 298 298
Low Blood Pressure/ Hypotension 294 660
Insufficient Information 251 507
Cardiac Arrest 220 586
Dyspnea 209 453
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 208 218
Loss of consciousness 100 588
Vomiting 97 463
Nausea 94 460
Chest Pain 85 85
Itching Sensation 78 200
No Consequences Or Impact To Patient 74 74
Dizziness 68 68
No Known Impact Or Consequence To Patient 63 63
High Blood Pressure/ Hypertension 58 180
No Patient Involvement 57 57
Diaphoresis 55 55
Discomfort 46 46
Low Oxygen Saturation 42 42
Abdominal Pain 39 161
Swelling/ Edema 37 37
Thrombocytopenia 36 280
Anemia 35 35
Headache 35 157
Tachycardia 34 34
Cramp(s) /Muscle Spasm(s) 29 29
Weight Changes 28 28
Hemolysis 28 28
Rash 28 28
Chills 26 270
Syncope/Fainting 25 25
Cough 24 24
Air Embolism 23 23
Convulsion/Seizure 22 144
Shaking/Tremors 21 21
Malaise 20 142
Hypervolemia 20 142
Bradycardia 19 19
Fatigue 18 18
Death 18 262
Urticaria 17 139
Hypernatremia 17 17
Blood Loss 16 16
Pain 16 16
Confusion/ Disorientation 15 15
Hypovolemia 15 15
Anxiety 13 13
Muscle Weakness 13 135

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Apr-15-2022
2 Baxter Healthcare Corporation I Nov-13-2024
3 Baxter Healthcare Corporation II Dec-22-2022
4 Baxter Healthcare Corporation II Dec-22-2022
5 Baxter Healthcare Corporation II Oct-12-2022
6 Baxter Healthcare Corporation II Apr-22-2022
7 Baxter Healthcare Corporation II Nov-11-2021
8 Baxter Healthcare Corporation II Aug-27-2021
9 Baxter Healthcare Corporation II Mar-19-2021
10 Baxter Healthcare Corporation II Feb-26-2021
11 Fresenius Medical Care Holdings, Inc. II Dec-17-2025
12 Fresenius Medical Care Holdings, Inc. II Jun-18-2025
13 Fresenius Medical Care Holdings, Inc. II Jan-03-2025
14 Fresenius Medical Care Holdings, Inc. II Sep-11-2024
15 Fresenius Medical Care Holdings, Inc. II Jul-11-2024
16 Fresenius Medical Care Holdings, Inc. II May-17-2024
17 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
18 Fresenius Medical Care Holdings, Inc. II Dec-20-2022
19 Fresenius Medical Care Holdings, Inc. II Jun-30-2022
20 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
21 Nipro Medical Corporation II Dec-11-2025
22 Nuwellis Inc I Jan-16-2025
23 NxStage MDS Corporation II Feb-27-2024
24 Outset Medical, Inc. II Oct-03-2024
25 Outset Medical, Inc. II Jun-14-2024
26 Outset Medical, Inc. I Apr-12-2024
27 Outset Medical, Inc. II Mar-21-2022
28 VANTIVE US HEALTHCARE LLC II Feb-02-2026
29 VANTIVE US HEALTHCARE LLC II Aug-26-2025
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