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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
  1.  K201167  AireHealth NebulizerTM
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 LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 107 107
2024 102 103
2025 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 168 168
Connection Problem 55 55
Leak/Splash 48 48
Break 47 47
Defective Device 36 38
Use of Device Problem 26 26
Adverse Event Without Identified Device or Use Problem 26 26
Mechanical Problem 25 25
Disconnection 23 23
Therapeutic or Diagnostic Output Failure 22 25
Insufficient Information 20 20
Fluid/Blood Leak 18 18
Improper Flow or Infusion 17 18
Melted 17 17
Patient Device Interaction Problem 15 15
Failure to Infuse 15 15
Infusion or Flow Problem 14 14
Obstruction of Flow 13 23
Output Problem 13 13
Fire 12 12
Smoking 12 12
Defective Component 12 12
Fitting Problem 11 11
Increase in Pressure 11 11
Material Rupture 10 10
Detachment of Device or Device Component 10 20
Gas/Air Leak 9 9
Insufficient Flow or Under Infusion 9 10
Component Missing 9 11
Electrical /Electronic Property Problem 9 9
Failure to Power Up 9 9
Overheating of Device 8 8
Appropriate Term/Code Not Available 8 8
No Flow 7 17
Loose or Intermittent Connection 7 7
Unexpected Shutdown 7 7
Inaccurate Delivery 7 7
Thermal Decomposition of Device 6 6
Degraded 6 6
Material Integrity Problem 6 6
Sparking 6 6
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Unexpected Therapeutic Results 5 5
Partial Blockage 5 5
Improper or Incorrect Procedure or Method 5 5
Temperature Problem 5 5
Protective Measures Problem 4 5
Restricted Flow rate 4 4
Product Quality Problem 4 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 372 387
No Consequences Or Impact To Patient 149 149
Insufficient Information 126 126
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 19 19
Dyspnea 17 18
Unspecified Respiratory Problem 10 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Unintended Extubation 5 5
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unspecified Infection 4 4
Respiratory Insufficiency 4 4
No Information 4 4
Pneumonia 4 4
Asthma 4 5
Cyanosis 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
Cough 3 3
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Pulmonary Edema 2 2
Bradycardia 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Hypertension 2 2
Apnea 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Muscle Weakness 2 2
Pulmonary Emphysema 2 2
Respiratory Distress 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Sleep Dysfunction 1 2
Decreased Respiratory Rate 1 1
Respiratory Failure 1 1

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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