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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 4
AEROGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE, INC.
  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
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 2
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 175 175

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 107 107
Infusion or Flow Problem 46 46
Connection Problem 32 32
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Leak/Splash 20 20
Disconnection 18 18
Melted 17 17
Failure to Infuse 14 14
Insufficient Heating 14 14
Insufficient Device Problem Information 14 14
Mechanical Problem 13 13
Smoking 12 13
Obstruction of Flow 12 12
Increase in Pressure 11 11
Improper Flow or Infusion 11 11
Fluid/Blood Leak 10 10
Break 10 10
Insufficient Flow or Under Infusion 9 10
Fire 9 9
Overheating of Device 8 8
Loose or Intermittent Connection 8 8
Defective Device 8 8
Failure to Power Up 7 7
Gas/Air Leak 7 7
Material Integrity Problem 6 6
Output Problem 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Unexpected Shutdown 5 5
Sparking 5 5
Patient Device Interaction Problem 5 5
Thermal Decomposition of Device 5 5
Degraded 5 5
Electrical /Electronic Property Problem 5 5
No Flow 5 5
Partial Blockage 4 4
Material Too Soft/Flexible 4 4
Temperature Problem 4 4
Restricted Flow rate 4 4
Unexpected Therapeutic Results 4 4
No Device Output 4 4
Detachment of Device or Device Component 4 4
Device Emits Odor 3 3
Inaccurate Delivery 3 3
Material Rupture 3 3
Component Missing 3 3
Charging Problem 3 3
Defective Component 3 3
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 520 536
Insufficient Information 166 166
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 19 19
Dyspnea 18 19
Unspecified Respiratory Problem 16 18
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Pneumonia 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Asthma 4 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Bronchospasm 4 4
Arrhythmia 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Headache 3 3
Cyanosis 3 3
No Information 3 3
Unspecified Infection 3 3
Bacterial Infection 3 3
Itching Sensation 3 3
Hypoxia 3 3
Fibrosis 2 2
Rash 2 2
Pulmonary Emphysema 2 2
Hypersensitivity/Allergic reaction 2 2
Heart Failure/Congestive Heart Failure 2 2
Chest Pain 2 2
Burn(s) 2 2
Pulmonary Edema 2 2
Sore Throat 2 2
Pneumothorax 2 2
Decreased Respiratory Rate 2 2
Respiratory Failure 2 2
Sleep Dysfunction 2 3
High Pulmonary Arterial Wedge Pressure 2 2
Airway Obstruction 2 2
Bronchitis 2 2
Muscle Weakness/Atrophy 2 2
Viral Infection 2 2
Pulmonary Hypertension 2 2
Urinary Frequency / Polyuria 2 2
Apnea 2 2
Loss of consciousness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Smiths Medical ASD Inc. II Apr-29-2021
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