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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
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
2019 185 189
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 163 163
Connection Problem 57 57
Infusion or Flow Problem 48 48
Leak/Splash 44 44
Disconnection 24 24
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Fluid/Blood Leak 17 17
Melted 17 17
Insufficient Device Problem Information 15 15
Insufficient Heating 14 14
Failure to Infuse 14 14
Mechanical Problem 13 13
Smoking 12 13
Improper Flow or Infusion 12 12
Obstruction of Flow 12 12
Break 12 12
Increase in Pressure 11 11
Material Rupture 10 10
Gas/Air Leak 10 10
Defective Device 9 9
Fire 9 9
Insufficient Flow or Under Infusion 9 10
Overheating of Device 9 9
Electrical /Electronic Property Problem 8 8
Fitting Problem 8 8
Loose or Intermittent Connection 8 8
Failure to Power Up 7 7
Material Integrity Problem 6 6
Inaccurate Delivery 6 6
Degraded 6 6
Thermal Decomposition of Device 6 6
Sparking 6 6
Output Problem 6 6
No Flow 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Patient Device Interaction Problem 5 5
Defective Component 5 5
Unexpected Shutdown 5 5
Unexpected Therapeutic Results 4 4
Restricted Flow rate 4 4
Partial Blockage 4 4
Material Too Soft/Flexible 4 4
Temperature Problem 4 4
Detachment of Device or Device Component 4 4
No Device Output 4 4
Contamination /Decontamination Problem 3 3
Off-Label Use 3 3
Improper or Incorrect Procedure or Method 3 3
Device Emits Odor 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 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 16 18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Pneumonia 5 5
Respiratory Insufficiency 4 4
Asthma 4 5
No Information 4 4
Unspecified Infection 4 4
Bronchospasm 4 4
Arrhythmia 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Itching Sensation 3 3
Cyanosis 3 3
Bacterial Infection 3 3
Headache 3 3
Hypoxia 3 3
Sore Throat 2 2
Rash 2 2
Bradycardia 2 2
Loss of consciousness 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Burn(s) 2 2
Bronchitis 2 2
Fibrosis 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pulmonary Emphysema 2 2
Urinary Frequency / Polyuria 2 2
Muscle Weakness/Atrophy 2 2
Chest Pain 2 2
Respiratory Distress 2 2
Pulmonary Edema 2 2
Sleep Dysfunction 2 3
Respiratory Failure 2 2
Airway Obstruction 2 2
Pulmonary Hypertension 2 2
Heart Failure/Congestive Heart Failure 2 2
Viral Infection 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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