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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
  1.  K170886  HOMED Mesh Nebulizer
  2.  K212395  Nebulizer
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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 203 203
Connection Problem 72 72
Leak/Splash 71 71
Break 67 67
Disconnection 46 46
Defective Device 45 47
Therapeutic or Diagnostic Output Failure 32 35
Adverse Event Without Identified Device or Use Problem 31 31
Use of Device Problem 29 29
Mechanical Problem 28 28
Fitting Problem 27 27
Fluid/Blood Leak 26 26
Insufficient Information 22 22
Output Problem 20 20
Electrical /Electronic Property Problem 19 19
Infusion or Flow Problem 19 19
Improper Flow or Infusion 19 20
Gas/Air Leak 18 18
Melted 17 17
Patient Device Interaction Problem 17 17
Obstruction of Flow 17 27
Failure to Infuse 16 16
Detachment of Device or Device Component 16 26
Defective Component 15 15
No Flow 14 24
Material Rupture 14 14
Smoking 13 14
Fire 13 13
Increase in Pressure 11 11
Loose or Intermittent Connection 10 10
Failure to Power Up 10 10
Inaccurate Delivery 10 10
Component Missing 10 12
Insufficient Flow or Under Infusion 9 10
Overheating of Device 9 9
Unexpected Shutdown 8 8
Degraded 8 8
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Improper or Incorrect Procedure or Method 6 6
Sparking 6 6
Charging Problem 5 5
Partial Blockage 5 5
Unexpected Therapeutic Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Temperature Problem 5 5
Noise, Audible 5 5
Failure to Charge 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 415 431
No Consequences Or Impact To Patient 231 231
Insufficient Information 143 143
No Known Impact Or Consequence To Patient 93 96
No Patient Involvement 80 80
Low Oxygen Saturation 21 21
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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