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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device humidifier, respiratory gas, (direct patient interface)
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL AG & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 6
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 7
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRUENDLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRUNDLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDISIZE BV
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC MEDICO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K132857  RESPIRATORY GAS HUMIDIFIER
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS, ARVIN FACILITY
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNETICS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 3
VENTLAB CORP.
  SUBSTANTIALLY EQUIVALENT 1
VINCENT HEALTHCARE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 716 716
2015 669 669
2016 1094 1094
2017 1007 1007
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 704 704
2024 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 4340 4340
Leak/Splash 609 609
Crack 525 525
Break 454 454
Material Split, Cut or Torn 426 426
Fluid/Blood Leak 404 404
Insufficient Heating 399 399
Failure to Power Up 376 376
Power Problem 287 287
Device Alarm System 245 245
Device Operates Differently Than Expected 217 217
Connection Problem 205 205
Temperature Problem 187 187
Detachment of Device or Device Component 153 153
Melted 107 107
Overheating of Device 93 93
Defective Alarm 89 89
Complete Loss of Power 83 83
Disconnection 78 78
Gas/Air Leak 75 75
Adverse Event Without Identified Device or Use Problem 69 69
Mechanical Problem 63 63
Device Displays Incorrect Message 57 57
Overfill 54 54
Device Issue 46 46
Insufficient Information 36 36
No Flow 35 35
Moisture or Humidity Problem 34 34
Therapeutic or Diagnostic Output Failure 33 33
Use of Device Problem 33 33
Hole In Material 32 32
Failure of Device to Self-Test 31 31
Device Handling Problem 29 29
Material Puncture/Hole 29 29
Defective Component 28 28
Device Sensing Problem 28 28
Infusion or Flow Problem 28 28
No Audible Prompt/Feedback 27 27
Obstruction of Flow 26 26
Protective Measures Problem 26 26
Improper or Incorrect Procedure or Method 25 25
Device Stops Intermittently 24 24
Improper Flow or Infusion 24 24
Air Leak 23 23
No Display/Image 22 22
Fitting Problem 22 22
Stretched 20 20
Loss of Power 20 20
Defective Device 20 20
Detachment Of Device Component 20 20
Misconnection 19 19
Loose or Intermittent Connection 19 19
Device Emits Odor 19 19
Failure to Deliver 19 19
Unexpected Shutdown 19 19
Difficult to Open or Close 18 18
False Alarm 18 18
Output Problem 17 17
No Apparent Adverse Event 16 16
Noise, Audible 15 15
Appropriate Term/Code Not Available 14 14
Filling Problem 14 14
Fire 14 14
Failure to Sense 14 14
Smoking 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Contamination /Decontamination Problem 12 12
Unintended Movement 12 12
Pressure Problem 12 12
Material Integrity Problem 11 11
Failure to Read Input Signal 11 11
Kinked 11 11
Loss of or Failure to Bond 10 10
Display or Visual Feedback Problem 10 10
Cut In Material 10 10
Material Deformation 10 10
Intermittent Loss of Power 9 9
Sparking 9 9
Material Separation 9 9
Device Inoperable 9 9
Thermal Decomposition of Device 9 9
Burst Container or Vessel 9 9
Moisture Damage 8 8
Device Damaged Prior to Use 8 8
Tear, Rip or Hole in Device Packaging 8 8
Component Missing 8 8
Restricted Flow rate 7 7
Partial Blockage 7 7
Electrical /Electronic Property Problem 7 7
Corroded 7 7
Degraded 6 6
Circuit Failure 6 6
No Device Output 6 6
Device Slipped 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Torn Material 6 6
Excessive Heating 6 6
Device Contamination with Chemical or Other Material 6 6
Failure to Select Signal 5 5
Split 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3175 3175
No Patient Involvement 2943 2943
No Known Impact Or Consequence To Patient 1749 1749
No Consequences Or Impact To Patient 1317 1318
Low Oxygen Saturation 266 266
No Information 118 118
Insufficient Information 91 91
Death 38 38
Burn(s) 27 27
Respiratory Distress 14 14
No Code Available 13 13
Bradycardia 11 11
Hypoxia 11 11
Partial thickness (Second Degree) Burn 11 11
Cardiac Arrest 9 9
Dyspnea 9 9
Obstruction/Occlusion 8 8
Superficial (First Degree) Burn 7 7
Aspiration/Inhalation 7 7
Pneumonia 6 6
Discomfort 6 6
Patient Problem/Medical Problem 5 5
Burn, Thermal 5 5
Viral Infection 4 4
Tachycardia 4 4
Airway Obstruction 4 4
Cancer 4 4
Cough 4 4
Unspecified Respiratory Problem 4 4
Respiratory Arrest 3 3
Erythema 3 3
Complaint, Ill-Defined 3 3
Full thickness (Third Degree) Burn 3 3
Injury 2 2
Pressure Sores 2 2
Ventilator Dependent 2 2
Decreased Respiratory Rate 2 2
Increased Respiratory Rate 2 2
Pneumothorax 2 2
Cyanosis 2 2
Unspecified Infection 2 2
Inflammation 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Asthma 1 1
Bacterial Infection 1 1
Skin Erosion 1 1
Swelling 1 1
Virus 1 1
Burning Sensation 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Hypoventilation 1 1
Hypovolemic Shock 1 1
Arrhythmia 1 1
Abnormal Blood Gases 1 1
Abrasion 1 1
Adult Respiratory Distress Syndrome 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Respiratory Failure 1 1
Resuscitation 1 1
Respiratory Tract Infection 1 1
Chest Tightness/Pressure 1 1
Nasal Obstruction 1 1
Distress 1 1
Therapeutic Response, Decreased 1 1
Inadequate Pain Relief 1 1
Fibrosis 1 1
Inadequate Osseointegration 1 1
Underdose 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Vitrectomy 1 1
Respiratory Insufficiency 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Epistaxis 1 1
Multiple Organ Failure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Medical AG III Jul-14-2022
2 TELEFLEX MEDICAL INC I Feb-07-2020
3 Telefelx Medical II Mar-09-2010
4 Teleflex Medical II Dec-15-2015
5 Teleflex Medical II Apr-30-2015
6 Teleflex Medical II Feb-12-2015
7 Teleflex Medical II Jul-23-2014
8 Teleflex Medical II Jul-07-2014
9 Teleflex Medical II Jul-19-2012
10 Teleflex Medical II Jul-12-2011
11 Teleflex Medical I Aug-13-2010
12 Vapotherm II Mar-17-2023
13 Vapotherm, Inc. II Sep-25-2014
14 Vyaire Medical I Jan-24-2018
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