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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 9
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 LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
  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
  1.  K244035  Portable mesh nebulizer (JM821)
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
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 201 201
Connection Problem 70 70
Leak/Splash 67 67
Break 52 52
Disconnection 46 46
Defective Device 37 39
Mechanical Problem 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Fitting Problem 26 26
Use of Device Problem 26 26
Fluid/Blood Leak 23 23
Therapeutic or Diagnostic Output Failure 22 25
Insufficient Information 22 22
Improper Flow or Infusion 19 20
Electrical /Electronic Property Problem 19 19
Melted 17 17
Obstruction of Flow 16 26
Patient Device Interaction Problem 16 16
Infusion or Flow Problem 16 16
Output Problem 15 15
Failure to Infuse 15 15
Gas/Air Leak 14 14
Material Rupture 14 14
Detachment of Device or Device Component 14 24
No Flow 13 23
Defective Component 13 13
Fire 13 13
Smoking 12 12
Increase in Pressure 11 11
Failure to Power Up 10 10
Inaccurate Delivery 9 9
Insufficient Flow or Under Infusion 9 10
Overheating of Device 9 9
Component Missing 9 11
Appropriate Term/Code Not Available 8 8
Loose or Intermittent Connection 8 8
Degraded 8 8
Unexpected Shutdown 7 7
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Improper or Incorrect Procedure or Method 6 6
Sparking 6 6
Partial Blockage 5 5
Unexpected Therapeutic Results 5 5
Charging Problem 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Temperature Problem 5 5
Restricted Flow rate 4 4
Device Operates Differently Than Expected 4 4

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 231 231
Insufficient Information 126 126
No Known Impact Or Consequence To Patient 93 96
No Patient Involvement 80 80
Low Oxygen Saturation 19 19
Dyspnea 17 18
Unspecified Respiratory Problem 10 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Aspiration/Inhalation 6 6
Respiratory Distress 6 6
Swelling/ Edema 6 6
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unintended Extubation 5 5
Asthma 5 6
Pneumonia 5 5
Dizziness 5 5
Unspecified Infection 4 4
Respiratory Insufficiency 4 4
Bronchospasm 4 4
Itching Sensation 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Hypoxia 3 3
Bacterial Infection 3 3
No Code Available 3 3
Headache 3 3
Arrhythmia 3 3
Apnea 3 3
Cyanosis 3 3
Urinary Frequency 2 2
Pulmonary Edema 2 2
Sore Throat 2 2
Bradycardia 2 2
Loss of consciousness 2 2
Fibrosis 2 2
Cardiopulmonary Arrest 2 2
Airway Obstruction 2 2
Chest Pain 2 2
Bronchitis 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Hypertension 2 2
Death 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Muscle Weakness 2 2
Pulmonary Emphysema 2 2
High Pulmonary Arterial Wedge Pressure 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
5 Valeant Pharmacueticals International II Jan-17-2018
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