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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 9
AEROGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
COGNITA LABS, LLC
  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
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 4
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
2019 185 189
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 203 203
Connection Problem 71 71
Leak/Splash 70 70
Break 65 65
Disconnection 46 46
Defective Device 44 46
Therapeutic or Diagnostic Output Failure 30 33
Adverse Event Without Identified Device or Use Problem 30 30
Fitting Problem 27 27
Use of Device Problem 27 27
Mechanical Problem 27 27
Fluid/Blood Leak 25 25
Insufficient Information 22 22
Electrical /Electronic Property Problem 19 19
Improper Flow or Infusion 19 20
Infusion or Flow Problem 19 19
Output Problem 19 19
Patient Device Interaction Problem 17 17
Melted 17 17
Gas/Air Leak 17 17
Obstruction of Flow 16 26
Failure to Infuse 16 16
Detachment of Device or Device Component 15 25
Defective Component 14 14
Material Rupture 14 14
Fire 13 13
No Flow 13 23
Smoking 13 14
Increase in Pressure 11 11
Component Missing 10 12
Failure to Power Up 10 10
Loose or Intermittent Connection 10 10
Insufficient Flow or Under Infusion 9 10
Inaccurate Delivery 9 9
Overheating of Device 9 9
Unexpected Shutdown 8 8
Appropriate Term/Code Not Available 8 8
Degraded 8 8
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Improper or Incorrect Procedure or Method 6 6
Sparking 6 6
Partial Blockage 5 5
Charging Problem 5 5
Unexpected Therapeutic Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Temperature Problem 5 5
Failure to Charge 5 5
Restricted Flow rate 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 403 419
No Consequences Or Impact To Patient 231 231
Insufficient Information 141 141
No Known Impact Or Consequence To Patient 93 96
No Patient Involvement 80 80
Low Oxygen Saturation 20 20
Dyspnea 18 19
Unspecified Respiratory Problem 11 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Swelling/ Edema 6 6
Respiratory Distress 6 6
Aspiration/Inhalation 6 6
Bronchospasm 5 5
Pneumonia 5 5
Unintended Extubation 5 5
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Asthma 5 6
Unspecified Infection 4 4
Respiratory Insufficiency 4 4
Cough 3 3
Increased Respiratory Rate 3 3
Cyanosis 3 3
Apnea 3 3
Arrhythmia 3 3
No Code Available 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
Itching Sensation 3 3
Heart Failure/Congestive Heart Failure 2 2
Bradycardia 2 2
Pulmonary Edema 2 2
Cardiopulmonary Arrest 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Emphysema 2 2
Fibrosis 2 2
Muscle Weakness 2 2
Urinary Frequency 2 2
Sore Throat 2 2
Loss of consciousness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Airway Obstruction 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Death 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company I Feb-04-2019
3 SANRAI INTERNATIONAL LLC II Mar-26-2019
4 Smiths Medical ASD Inc. II Apr-29-2021
5 Valeant Pharmacueticals International II Jan-17-2018
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