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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
NIPRO MEDICAL CORPORATION
  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 888 888

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8824 9075
Adverse Event Without Identified Device or Use Problem 1004 2590
Break 644 644
Thermal Decomposition of Device 585 585
Crack 366 366
Inadequate Ultra Filtration 338 338
Device Contamination with Chemical or Other Material 226 226
Labelling, Instructions for Use or Training Problem 183 183
Leak/Splash 169 175
Air/Gas in Device 161 293
Obstruction of Flow 133 141
Detachment of Device or Device Component 113 113
Melted 105 105
Protective Measures Problem 98 98
Disconnection 93 93
Smoking 80 80
Calibration Problem 69 69
No Apparent Adverse Event 66 66
Improper or Incorrect Procedure or Method 66 188
Material Puncture/Hole 53 53
Device Alarm System 47 48
Loose or Intermittent Connection 42 52
Improper Flow or Infusion 37 37
Therapeutic or Diagnostic Output Failure 37 166
Filtration Problem 35 35
Material Split, Cut or Torn 34 34
Mechanical Problem 34 34
Use of Device Problem 30 30
Infusion or Flow Problem 29 29
Sparking 28 28
Patient-Device Incompatibility 28 150
No Audible Alarm 28 28
Unexpected Shutdown 26 27
Material Rupture 25 147
Insufficient Information 23 145
Fire 23 23
Output Problem 22 22
Filling Problem 22 22
Pressure Problem 22 32
Reflux within Device 21 21
Defective Device 20 20
Biocompatibility 20 20
Defective Component 19 31
Connection Problem 19 19
No Display/Image 17 18
Product Quality Problem 16 27
Priming Problem 16 16
Display or Visual Feedback Problem 16 16
Device Displays Incorrect Message 16 18
Defective Alarm 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7732 7739
Hemorrhage/Bleeding 3535 4147
Hypersensitivity/Allergic reaction 304 304
Low Blood Pressure/ Hypotension 299 665
Insufficient Information 251 507
Cardiac Arrest 228 594
Dyspnea 214 458
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 210 220
Loss of consciousness 100 588
Vomiting 98 464
Nausea 96 462
Chest Pain 88 88
Itching Sensation 81 203
No Consequences Or Impact To Patient 74 74
Dizziness 70 70
No Known Impact Or Consequence To Patient 63 63
High Blood Pressure/ Hypertension 59 181
No Patient Involvement 57 57
Diaphoresis 56 56
Discomfort 46 46
Low Oxygen Saturation 42 42
Abdominal Pain 39 161
Swelling/ Edema 38 38
Thrombocytopenia 37 281
Tachycardia 36 36
Anemia 35 35
Headache 35 157
Cramp(s) /Muscle Spasm(s) 29 29
Hemolysis 29 29
Weight Changes 28 28
Rash 28 28
Syncope/Fainting 26 26
Chills 26 270
Cough 25 25
Air Embolism 24 24
Convulsion/Seizure 22 144
Shaking/Tremors 21 21
Bradycardia 20 20
Hypervolemia 20 142
Malaise 20 142
Urticaria 19 141
Fatigue 18 18
Death 18 262
Hypernatremia 17 17
Pain 16 16
Blood Loss 16 16
Confusion/ Disorientation 15 15
Hypovolemia 15 15
Hot Flashes/Flushes 13 13
Anxiety 13 13

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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