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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)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 3
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 11
  1.  K191818  F&P Optiflow 3S Nasal Cannula (Small, Medium, Larg ...
  2.  K201723  F&P Optiflow Nasal Oxygen Cannula with CO2 Samplin ...
  3.  K211096  Optiflow Oxygen Kit
  4.  K212031  F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
  5.  K222197  F&P Optiflow Junior 2/2+ Nasal Cannula Interface R ...
  6.  K223684  F&P 820 Humidification System
  7.  K231956  F&P Optiflow+ Duet Nasal Cannula
  8.  K233821  F&P Optiflow Oxygen Kit (AA451J)
  9.  K234058  F&P Optiflow Filtered Nasal Interface with Anesthe ...
  10.  K251611  Optiflow+ Nasal Cannula - Small (OPT942); Optiflow ...
  11.  K253479  Optiflow Switch+ Filtered Nasal Interface with CO2 ...
FLEXICARE MEDICAL LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 3
PERMA PURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1198
2021 1510 1511
2022 749 749
2023 716 736
2024 500 505
2025 1755 1759
2026 391 391

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3308 3308
Defective Alarm 1439 1441
Material Split, Cut or Torn 598 603
Leak/Splash 473 479
Crack 469 473
Detachment of Device or Device Component 426 437
Break 402 417
Fluid/Blood Leak 373 374
Insufficient Heating 307 307
Failure to Power Up 186 186
Device Alarm System 138 138
Gas/Air Leak 136 136
Melted 108 108
Mechanical Problem 92 93
Complete Loss of Power 83 83
Adverse Event Without Identified Device or Use Problem 66 66
Disconnection 61 63
Power Problem 58 58
Stretched 52 53
Temperature Problem 52 52
Overfill 51 51
Insufficient Information 47 47
Material Puncture/Hole 42 42
Device Dislodged or Dislocated 33 33
Therapeutic or Diagnostic Output Failure 32 34
Overheating of Device 31 32
Use of Device Problem 29 29
Defective Component 27 27
No Audible Prompt/Feedback 27 27
Infusion or Flow Problem 27 27
Obstruction of Flow 25 25
Moisture or Humidity Problem 20 20
Connection Problem 20 21
Unexpected Shutdown 20 20
Loose or Intermittent Connection 20 20
Improper Flow or Infusion 19 19
Defective Device 18 18
Device Displays Incorrect Message 18 18
Output Problem 17 17
Improper or Incorrect Procedure or Method 17 17
Misconnection 17 17
No Flow 16 18
No Apparent Adverse Event 16 16
Protective Measures Problem 15 15
Material Integrity Problem 14 14
Fire 14 14
Difficult to Open or Close 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Unintended Movement 13 13
Failure to Deliver 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5588 5622
No Patient Involvement 1279 1279
No Known Impact Or Consequence To Patient 920 922
No Consequences Or Impact To Patient 319 320
Low Oxygen Saturation 308 310
Insufficient Information 118 119
Death 25 25
Hypoxia 19 19
Burn(s) 17 17
No Information 14 14
Partial thickness (Second Degree) Burn 11 11
Bradycardia 10 10
Cardiac Arrest 10 10
Superficial (First Degree) Burn 8 8
Respiratory Distress 7 7
Unspecified Respiratory Problem 7 7
Cough 6 6
Obstruction/Occlusion 6 6
Aspiration/Inhalation 5 5
Dyspnea 5 5
Airway Obstruction 4 4
Cancer 4 4
Tachycardia 4 4
Pneumonia 4 4
Viral Infection 4 4
Discomfort 4 4
Patient Problem/Medical Problem 3 3
Respiratory Failure 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Arrest 3 3
Blister 3 3
Distress 2 2
Pressure Sores 2 2
Increased Respiratory Rate 2 2
Pain 2 2
Burn, Thermal 2 3
Asthma 2 2
No Code Available 2 2
Skin Inflammation/ Irritation 2 2
Bronchitis 1 1
Unspecified Infection 1 1
Decreased Respiratory Rate 1 1
Ventilator Dependent 1 1
Sleep Dysfunction 1 1
Low Blood Pressure/ Hypotension 1 1
Cyanosis 1 1
Electric Shock 1 1
Complaint, Ill-Defined 1 1
Irritability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II Oct-15-2025
2 Fisher & Paykel Healthcare, Ltd. II May-15-2024
3 Hamilton Medical AG III Jul-14-2022
4 TELEFLEX MEDICAL INC I Feb-07-2020
5 Vapotherm II Mar-17-2023
6 Vyaire Medical I Jan-24-2018
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