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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 6
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
  1.  K202171  Pulmogine Vibrating Mesh Nebulizer
  2.  K250583  AdheResp Smart Breath-actuated Mesh Nebulizer
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
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 170 170
Break 60 60
Connection Problem 56 56
Leak/Splash 51 51
Defective Device 43 45
Therapeutic or Diagnostic Output Failure 30 33
Adverse Event Without Identified Device or Use Problem 29 29
Use of Device Problem 27 27
Mechanical Problem 25 25
Disconnection 23 23
Fluid/Blood Leak 20 20
Insufficient Information 20 20
Infusion or Flow Problem 17 17
Melted 17 17
Improper Flow or Infusion 17 18
Output Problem 17 17
Patient Device Interaction Problem 16 16
Failure to Infuse 16 16
Defective Component 13 13
Smoking 13 14
Obstruction of Flow 13 23
Fitting Problem 12 12
Fire 12 12
Gas/Air Leak 12 12
Detachment of Device or Device Component 11 21
Increase in Pressure 11 11
Component Missing 10 12
Material Rupture 10 10
Failure to Power Up 9 9
Electrical /Electronic Property Problem 9 9
Loose or Intermittent Connection 9 9
Insufficient Flow or Under Infusion 9 10
Overheating of Device 8 8
Appropriate Term/Code Not Available 8 8
Unexpected Shutdown 8 8
Inaccurate Delivery 7 7
No Flow 7 17
Thermal Decomposition of Device 6 6
Degraded 6 6
Material Integrity Problem 6 6
Sparking 6 6
Partial Blockage 5 5
Restricted Flow rate 5 5
Unexpected Therapeutic Results 5 5
Improper or Incorrect Procedure or Method 5 5
Temperature Problem 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Failure to Charge 5 5
Device Emits Odor 4 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 149 149
Insufficient Information 141 141
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 20 20
Dyspnea 18 19
Unspecified Respiratory Problem 11 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unintended Extubation 5 5
Bronchospasm 4 4
No Information 4 4
Respiratory Insufficiency 4 4
Unspecified Infection 4 4
Pneumonia 4 4
Asthma 4 5
Bacterial Infection 3 3
Arrhythmia 3 3
Cyanosis 3 3
Headache 3 3
Itching Sensation 3 3
Hypoxia 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Sleep Dysfunction 2 3
Viral Infection 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Pulmonary Hypertension 2 2
Fibrosis 2 2
Decreased Respiratory Rate 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Urinary Frequency 2 2
Muscle Weakness 2 2
Pneumothorax 2 2
Pulmonary Edema 2 2
Rash 2 2
Respiratory Distress 2 2
Hypersensitivity/Allergic reaction 2 2
Pulmonary Emphysema 2 2
Airway Obstruction 2 2
Apnea 2 2
Bradycardia 2 2
Bronchitis 2 2
Burn(s) 2 2
Chest Pain 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
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