Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device humidifier, respiratory gas, (direct patient interface)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
  1.  K191818  F&P Optiflow 3S Nasal Cannula (Small, Medium, Larg ...
  2.  K212031  F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
  3.  K222197  F&P Optiflow Junior 2/2+ Nasal Cannula Interface R ...
  4.  K223684  F&P 820 Humidification System
  5.  K231956  F&P Optiflow+ Duet Nasal Cannula
  6.  K233821  F&P Optiflow Oxygen Kit (AA451J)
  7.  K234058  F&P Optiflow Filtered Nasal Interface with Anesthe ...
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 7
  1.  K191818  F&P Optiflow 3S Nasal Cannula (Small, Medium, Larg ...
  2.  K212031  F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
  3.  K222197  F&P Optiflow Junior 2/2+ Nasal Cannula Interface R ...
  4.  K223684  F&P 820 Humidification System
  5.  K231956  F&P Optiflow+ Duet Nasal Cannula
  6.  K233821  F&P Optiflow Oxygen Kit (AA451J)
  7.  K234058  F&P Optiflow Filtered Nasal Interface with Anesthe ...
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP.
  SUBSTANTIALLY EQUIVALENT 2
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VINCENT HEALTHCARE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 718 718
2024 501 501
2025 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3185 3185
Material Split, Cut or Torn 508 508
Leak/Splash 407 407
Crack 388 388
Break 357 357
Fluid/Blood Leak 314 314
Insufficient Heating 307 307
Detachment of Device or Device Component 210 210
Failure to Power Up 186 186
Device Alarm System 135 135
Gas/Air Leak 95 95
Melted 87 87
Complete Loss of Power 83 83
Defective Alarm 82 82
Mechanical Problem 76 76
Adverse Event Without Identified Device or Use Problem 62 62
Disconnection 59 59
Power Problem 58 58
Temperature Problem 51 51
Overfill 50 50
Insufficient Information 35 35
Therapeutic or Diagnostic Output Failure 32 32
Material Puncture/Hole 31 31
Overheating of Device 30 30
No Audible Prompt/Feedback 27 27
Stretched 27 27
Use of Device Problem 27 27
Defective Component 26 26
Obstruction of Flow 25 25
Infusion or Flow Problem 25 25
Improper Flow or Infusion 19 19
Unexpected Shutdown 19 19
Device Displays Incorrect Message 18 18
Defective Device 18 18
Improper or Incorrect Procedure or Method 17 17
Moisture or Humidity Problem 17 17
Connection Problem 17 17
Misconnection 16 16
No Apparent Adverse Event 16 16
Output Problem 16 16
No Flow 16 16
Protective Measures Problem 15 15
Difficult to Open or Close 14 14
Fire 13 13
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Unintended Movement 12 12
Contamination /Decontamination Problem 12 12
Loss of Power 12 12
Device Dislodged or Dislocated 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3570 3570
No Patient Involvement 1279 1279
No Known Impact Or Consequence To Patient 920 920
No Consequences Or Impact To Patient 319 319
Low Oxygen Saturation 256 256
Insufficient Information 102 102
Death 25 25
Burn(s) 16 16
Hypoxia 14 14
No Information 14 14
Cardiac Arrest 9 9
Bradycardia 9 9
Partial thickness (Second Degree) Burn 9 9
Respiratory Distress 7 7
Obstruction/Occlusion 6 6
Unspecified Respiratory Problem 6 6
Cancer 5 5
Superficial (First Degree) Burn 5 5
Dyspnea 4 4
Pneumonia 4 4
Viral Infection 4 4
Cough 4 4
Tachycardia 4 4
Airway Obstruction 4 4
Respiratory Arrest 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Failure 3 3
Discomfort 3 3
Patient Problem/Medical Problem 3 3
Aspiration/Inhalation 3 3
Pressure Sores 2 2
Increased Respiratory Rate 2 2
Blister 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pain 2 2
No Code Available 2 2
Distress 2 2
Asthma 2 2
Burn, Thermal 2 2
Low Blood Pressure/ Hypotension 1 1
Decreased Respiratory Rate 1 1
Virus 1 1
Burning Sensation 1 1
Skin Erosion 1 1
Heart Failure/Congestive Heart Failure 1 1
Stroke/CVA 1 1
Unspecified Infection 1 1
Inflammation 1 1
Fever 1 1
Myocardial Infarction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II May-15-2024
2 Hamilton Medical AG III Jul-14-2022
3 TELEFLEX MEDICAL INC I Feb-07-2020
4 Vapotherm II Mar-17-2023
5 Vyaire Medical I Jan-24-2018
-
-