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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
  1.  K243468  Compressor Nebulizer (NB-1100); Compressor Nebuliz ...
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 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 173 173
Break 71 71
Connection Problem 57 57
Defective Device 57 59
Leak/Splash 53 53
Infusion or Flow Problem 45 45
Therapeutic or Diagnostic Output Failure 37 40
Adverse Event Without Identified Device or Use Problem 32 32
Use of Device Problem 31 31
Mechanical Problem 27 27
Disconnection 24 24
Fluid/Blood Leak 23 23
Output Problem 21 21
Insufficient Information 20 20
Improper Flow or Infusion 17 18
Melted 17 17
Patient Device Interaction Problem 16 16
Failure to Infuse 16 16
Obstruction of Flow 14 24
Defective Component 14 14
Smoking 14 15
Fitting Problem 13 13
Gas/Air Leak 13 13
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
Material Rupture 10 10
Failure to Power Up 9 9
No Flow 9 19
Electrical /Electronic Property Problem 9 9
Overheating of Device 9 9
Insufficient Flow or Under Infusion 9 10
Inaccurate Delivery 8 8
Appropriate Term/Code Not Available 8 8
Unexpected Shutdown 8 8
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Degraded 6 6
Noise, Audible 6 6
Sparking 6 6
Partial Blockage 5 5
Restricted Flow rate 5 5
Crack 5 5
Unexpected Therapeutic Results 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Improper or Incorrect Procedure or Method 5 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 149 149
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 21 21
Dyspnea 18 19
Unspecified Respiratory Problem 12 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unintended Extubation 5 5
Pneumonia 5 5
Dizziness 5 5
Asthma 4 5
Bronchospasm 4 4
No Information 4 4
Respiratory Insufficiency 4 4
Unspecified Infection 4 4
Bacterial Infection 3 3
Headache 3 3
Hypoxia 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Arrhythmia 3 3
Itching Sensation 3 3
Cyanosis 3 3
Urinary Frequency 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Fibrosis 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Airway Obstruction 2 2
Bradycardia 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Bronchitis 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Sleep Dysfunction 2 3
Burn(s) 2 2
Pulmonary Hypertension 2 2
Apnea 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Muscle Weakness 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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