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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 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
  1.  K201397  Ultrasonic Mesh Nebulizer
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 185 185
2020 117 117
2021 161 161
2022 55 55
2023 107 107
2024 102 103
2025 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 167 167
Connection Problem 55 55
Leak/Splash 45 45
Break 35 35
Use of Device Problem 25 25
Disconnection 23 23
Defective Device 23 23
Mechanical Problem 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Fluid/Blood Leak 18 18
Insufficient Information 17 17
Melted 15 15
Improper Flow or Infusion 15 15
Therapeutic or Diagnostic Output Failure 14 14
Failure to Infuse 14 14
Infusion or Flow Problem 13 13
Output Problem 13 13
Fire 12 12
Patient Device Interaction Problem 11 11
Defective Component 10 10
Smoking 10 10
Material Rupture 10 10
Electrical /Electronic Property Problem 9 9
Gas/Air Leak 9 9
Failure to Power Up 8 8
Insufficient Flow or Under Infusion 8 9
Detachment of Device or Device Component 8 8
Appropriate Term/Code Not Available 8 8
Overheating of Device 8 8
Fitting Problem 8 8
Inaccurate Delivery 7 7
No Flow 7 7
Thermal Decomposition of Device 6 6
Unexpected Shutdown 6 6
Loose or Intermittent Connection 6 6
Component Missing 6 6
Degraded 6 6
Material Integrity Problem 5 5
Contamination 5 5
Sparking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Partial Blockage 4 4
Device Emits Odor 4 4
Product Quality Problem 4 4
Unexpected Therapeutic Results 4 4
Material Too Soft/Flexible 4 4
Improper or Incorrect Procedure or Method 4 4
Temperature Problem 4 4
Failure to Charge 4 4
Restricted Flow rate 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 338 339
No Consequences Or Impact To Patient 149 149
Insufficient Information 86 86
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 52 52
Low Oxygen Saturation 17 17
Dyspnea 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 8 8
Swelling/ Edema 6 6
Unintended Extubation 5 5
Dizziness 5 5
Aspiration/Inhalation 5 5
Respiratory Insufficiency 4 4
No Information 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Cyanosis 3 3
Unspecified Infection 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Increased Respiratory Rate 3 3
Asthma 3 3
Itching Sensation 3 3
Airway Obstruction 2 2
Fibrosis 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Hypoxia 2 2
Cough 2 2
Bronchospasm 2 2
Pneumonia 2 2
Bradycardia 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Hypertension 2 2
Apnea 2 2
Muscle Weakness 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
High Pulmonary Arterial Wedge Pressure 2 2
High Blood Pressure/ Hypertension 1 1
Decreased Respiratory Rate 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Low Blood Pressure/ Hypotension 1 1
Death 1 1
Electric Shock 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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