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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
FINDAIR SP. Z O.O.
  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
  1.  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 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 485 501

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 168 168
Infusion or Flow Problem 72 72
Connection Problem 60 60
Leak/Splash 51 51
No Flow 43 43
Fluid/Blood Leak 36 36
Break 32 32
Restricted Flow rate 32 32
Pressure Problem 28 28
Adverse Event Without Identified Device or Use Problem 28 28
Disconnection 27 27
Fitting Problem 25 25
Use of Device Problem 24 24
Insufficient Heating 21 37
Decrease in Pressure 19 19
Melted 19 19
Detachment of Device or Device Component 19 19
Gas/Air Leak 17 17
Failure to Power Up 16 16
Insufficient Device Problem Information 16 16
Output Problem 16 16
Crack 16 16
Loose or Intermittent Connection 15 15
Mechanical Problem 15 15
Failure to Infuse 14 14
Obstruction of Flow 13 13
Smoking 13 14
Improper Flow or Infusion 12 12
Defective Device 12 12
Material Rupture 11 11
Increase in Pressure 11 11
Overheating of Device 11 11
Electrical /Electronic Property Problem 11 27
Insufficient Flow or Under Infusion 10 11
Noise, Audible 10 10
Fire 9 9
Material Integrity Problem 7 7
Thermal Decomposition of Device 7 7
Unexpected Shutdown 7 7
Appropriate Device Problem Term/Code Not Available 6 6
Inaccurate Delivery 6 6
Therapeutic or Diagnostic Output Failure 6 6
Contamination 6 6
Gas Output Problem 6 6
Degraded 6 6
Sparking 6 6
Packaging Problem 5 5
Output below Specifications 5 5
Temperature Problem 5 5
Component Missing 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 809 841
Insufficient Information 177 177
No Consequences Or Impact To Patient 149 149
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 26 26
Dyspnea 18 19
Unspecified Respiratory Problem 17 19
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Bronchospasm 9 9
Pneumonia 7 7
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Chronic Obstructive Pulmonary Disease (COPD) 6 6
Unintended Extubation 5 5
Dizziness 5 5
Unspecified Infection 4 4
Respiratory Insufficiency 4 4
No Information 4 4
Asthma 4 5
Cyanosis 3 3
Increased Respiratory Rate 3 3
Arrhythmia 3 3
Cough 3 3
Hypoxia 3 3
Headache 3 3
Itching Sensation 3 3
Bacterial Infection 3 3
Heart Failure/Congestive Heart Failure 2 2
Bradycardia 2 2
Pulmonary Edema 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Urinary Frequency / Polyuria 2 2
Pulmonary Emphysema 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Fibrosis 2 2
Airway Obstruction 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Respiratory Distress 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Bronchitis 2 2
Pulmonary Hypertension 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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