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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nebulizer (direct patient interface)
Regulation Description Nebulizer.
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHERIUM (NZ), LTD.
  SUBSTANTIALLY EQUIVALENT 4
AEROGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENCHANT TEK CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXCELLENTCARE MEDICAL (HUIZHOU) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FEELLIFE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HCMED INNOVATIONS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANKIND PHARMA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 116 116
Break 69 69
Defective Device 54 56
Infusion or Flow Problem 43 43
Therapeutic or Diagnostic Output Failure 35 35
Connection Problem 32 32
Use of Device Problem 30 30
Adverse Event Without Identified Device or Use Problem 29 29
Mechanical Problem 27 27
Leak/Splash 26 26
Output Problem 20 20
Insufficient Information 19 19
Disconnection 18 18
Melted 17 17
Failure to Infuse 16 16
Patient Device Interaction Problem 16 16
Improper Flow or Infusion 15 16
Fluid/Blood Leak 15 15
Smoking 14 15
Obstruction of Flow 14 24
Insufficient Heating 13 13
Loose or Intermittent Connection 12 12
Fire 12 12
Detachment of Device or Device Component 12 22
Component Missing 11 13
Increase in Pressure 11 11
Defective Component 10 10
Gas/Air Leak 10 10
Insufficient Flow or Under Infusion 9 10
Failure to Power Up 9 9
Unexpected Shutdown 8 8
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 7 7
Overheating of Device 7 7
No Flow 7 17
Fitting Problem 7 7
Electrical /Electronic Property Problem 6 6
Noise, Audible 6 6
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Degraded 5 5
Partial Blockage 5 5
Thermal Decomposition of Device 5 5
Unexpected Therapeutic Results 5 5
Restricted Flow rate 5 5
Crack 5 5
Temperature Problem 5 5
Sparking 5 5
Failure to Charge 5 5
Protective Measures Problem 4 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 487 503
Insufficient Information 161 161
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 19 19
Dyspnea 18 19
No Patient Involvement 14 14
Unspecified Respiratory Problem 12 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Pneumonia 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Bronchospasm 4 4
Asthma 4 5
Cyanosis 3 3
Unspecified Infection 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
No Information 3 3
Hypoxia 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Decreased Respiratory Rate 2 2
Respiratory Failure 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Muscle Weakness 2 2
Pulmonary Emphysema 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Pulmonary Hypertension 2 2
Sleep Dysfunction 2 3

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Smiths Medical ASD Inc. II Apr-29-2021
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