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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, thermal regulating
Regulation Description Thermal regulating system.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeDWJ
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BRAINCOOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
HADLEIGH HEALTH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2294 2295
2020 2546 2546
2021 2689 2694
2022 3226 3228
2023 3455 3461
2024 3329 3334
2025 2261 2262

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2986 2987
Insufficient Cooling 2982 2983
Device Sensing Problem 2510 2516
Failure to Pump 2279 2279
Inaccurate Flow Rate 2076 2076
Insufficient Heating 1592 1593
Gas/Air Leak 1552 1552
Restricted Flow rate 1241 1241
Decreased Pump Speed 1015 1015
Temperature Problem 947 949
Circuit Failure 845 845
Pumping Problem 637 637
Failure to Calibrate 539 539
Device Displays Incorrect Message 500 500
Computer Operating System Problem 484 484
Overheating of Device 370 370
Operating System Becomes Nonfunctional 356 356
Fluid/Blood Leak 279 279
Nonstandard Device 278 278
Device Alarm System 229 229
Material Fragmentation 216 216
Adverse Event Without Identified Device or Use Problem 209 210
Improper or Incorrect Procedure or Method 209 209
Use of Device Problem 190 190
Therapeutic or Diagnostic Output Failure 182 183
Overfill 178 179
Calibration Problem 178 178
Infusion or Flow Problem 167 167
Power Problem 162 162
Display or Visual Feedback Problem 156 157
Protective Measures Problem 132 132
No Flow 130 130
Fitting Problem 118 119
Lack of Effect 117 117
Defective Device 113 113
Deformation Due to Compressive Stress 112 112
Material Split, Cut or Torn 108 108
Insufficient Information 103 103
Insufficient Flow or Under Infusion 98 98
Patient Device Interaction Problem 91 91
Alarm Not Visible 89 90
Computer Software Problem 88 88
Material Separation 84 84
Biocompatibility 83 83
Electrical Shorting 82 82
Filling Problem 80 80
Device Handling Problem 76 76
Component Missing 73 73
Failure to Sense 73 74
Leak/Splash 70 72

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14250 14264
No Known Impact Or Consequence To Patient 2851 2851
No Consequences Or Impact To Patient 2626 2626
No Patient Involvement 1585 1585
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1303 1304
Alteration In Body Temperature 330 330
Patient Problem/Medical Problem 258 258
Chills 213 213
Insufficient Information 121 123
No Code Available 119 119
Burn(s) 101 101
Inadequate Pain Relief 101 101
Partial thickness (Second Degree) Burn 56 59
Shaking/Tremors 55 55
Skin Discoloration 47 47
Convulsion/Seizure 47 47
Blister 35 35
Skin Tears 34 34
Death 34 34
No Information 32 32
Hypothermia 25 25
Erythema 23 24
Pressure Sores 23 23
Fever 23 23
Full thickness (Third Degree) Burn 23 23
Bradycardia 21 21
Alteration in Body Temperature 20 20
Discomfort 19 19
Seizures 17 17
Therapeutic Effects, Unexpected 17 17
Skin Inflammation/ Irritation 17 17
Superficial (First Degree) Burn 16 16
Burn, Thermal 15 15
Unspecified Infection 15 15
Paralysis 14 14
Rash 13 14
Pain 12 12
Sepsis 12 12
Low Blood Pressure/ Hypotension 11 11
Skin Irritation 9 9
Necrosis 9 9
Bacterial Infection 7 7
Cardiac Arrest 7 7
Tissue Breakdown 6 6
Burning Sensation 6 6
Swelling 6 6
Sedation 5 5
Tissue Damage 5 5
Electric Shock 5 5
Abrasion 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Augustine Temperature Management, LLC II Feb-20-2025
2 Augustine Temperature Management, LLC II Feb-14-2025
3 Augustine Temperature Management, LLC II Jan-10-2025
4 Augustine Temperature Management, LLC II Dec-18-2024
5 Bard Medical Division II Apr-27-2019
6 Belmont Instrument Corporation II Oct-31-2022
7 Belmont Instrument LLC II Jun-12-2025
8 Care Essentials Pty., Ltd. II Mar-03-2020
9 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
10 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
11 Medivance Inc. II Jul-31-2024
12 Medivance Inc. II Mar-26-2024
13 Pintler Medical LLC II Apr-12-2019
14 Tec Com Gmbh II Nov-12-2019
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