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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
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
  1.  K201397  Ultrasonic Mesh Nebulizer
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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 170 170
Break 62 62
Connection Problem 57 57
Leak/Splash 52 52
Defective Device 44 46
Therapeutic or Diagnostic Output Failure 32 35
Adverse Event Without Identified Device or Use Problem 30 30
Use of Device Problem 29 29
Mechanical Problem 26 26
Disconnection 23 23
Fluid/Blood Leak 21 21
Insufficient Information 20 20
Output Problem 18 18
Improper Flow or Infusion 17 18
Melted 17 17
Infusion or Flow Problem 17 17
Patient Device Interaction Problem 16 16
Failure to Infuse 16 16
Obstruction of Flow 14 24
Defective Component 14 14
Gas/Air Leak 13 13
Smoking 13 14
Fitting Problem 12 12
Fire 12 12
Detachment of Device or Device Component 12 22
Increase in Pressure 11 11
Component Missing 10 12
Material Rupture 10 10
Failure to Power Up 9 9
Insufficient Flow or Under Infusion 9 10
Electrical /Electronic Property Problem 9 9
Loose or Intermittent Connection 9 9
Inaccurate Delivery 8 8
Appropriate Term/Code Not Available 8 8
Unexpected Shutdown 8 8
Overheating of Device 8 8
No Flow 8 18
Thermal Decomposition of Device 6 6
Material Integrity Problem 6 6
Degraded 6 6
Sparking 6 6
Restricted Flow rate 5 5
Partial Blockage 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
Temperature Problem 5 5
Failure to Charge 5 5
Product Quality Problem 4 14

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 149 149
Insufficient Information 143 143
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 11 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unintended Extubation 5 5
Dizziness 5 5
Pneumonia 4 4
Bronchospasm 4 4
Asthma 4 5
Respiratory Insufficiency 4 4
No Information 4 4
Unspecified Infection 4 4
Headache 3 3
Bacterial Infection 3 3
Itching Sensation 3 3
Hypoxia 3 3
Arrhythmia 3 3
Cyanosis 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Loss of consciousness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Airway Obstruction 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Respiratory Distress 2 2
Muscle Weakness 2 2
Fibrosis 2 2
Pulmonary Emphysema 2 2
Hypersensitivity/Allergic reaction 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Burn(s) 2 2
Rash 2 2
Apnea 2 2
Respiratory Failure 2 2
Chest Pain 2 2
Viral Infection 2 2
Bronchitis 2 2
Sleep Dysfunction 2 3
Bradycardia 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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