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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
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
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN IVANKACA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4
  1.  K173367  MC 300* Nebulizer
  2.  K173825  MC 300R* Nebulizer
  3.  K200063  AeroEclipse* ONE BAN
  4.  K203400  Corrugated tube with mouthpiece accessory
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 107 108
2024 102 103
2025 193 193
2026 175 175

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 194 194
Connection Problem 72 72
Leak/Splash 63 63
Infusion or Flow Problem 50 50
Disconnection 47 47
Adverse Event Without Identified Device or Use Problem 24 24
Fitting Problem 23 23
Use of Device Problem 22 22
Fluid/Blood Leak 21 21
Electrical /Electronic Property Problem 18 18
Melted 17 17
Insufficient Device Problem Information 16 16
Gas/Air Leak 15 15
Mechanical Problem 14 14
Obstruction of Flow 14 14
Improper Flow or Infusion 14 14
Insufficient Heating 14 14
Failure to Infuse 14 14
Material Rupture 14 14
Break 12 12
No Flow 12 12
Smoking 12 13
Increase in Pressure 11 11
Overheating of Device 10 10
Fire 10 10
Loose or Intermittent Connection 9 9
Defective Device 9 9
Insufficient Flow or Under Infusion 9 10
Degraded 8 8
Failure to Power Up 8 8
Inaccurate Delivery 8 8
Detachment of Device or Device Component 7 7
Material Integrity Problem 6 6
Output Problem 6 6
Sparking 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Patient Device Interaction Problem 6 6
Thermal Decomposition of Device 6 6
Defective Component 5 5
Unexpected Shutdown 5 5
Temperature Problem 4 4
No Device Output 4 4
Material Too Soft/Flexible 4 4
Partial Blockage 4 4
Unexpected Therapeutic Results 4 4
Restricted Flow rate 4 4
Device Emits Odor 3 3
Off-Label Use 3 3
Material Split, Cut or Torn 3 3
Component Missing 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 520 536
No Consequences Or Impact To Patient 231 231
Insufficient Information 166 166
No Known Impact Or Consequence To Patient 93 96
No Patient Involvement 80 80
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
No Information 8 8
Aspiration/Inhalation 6 6
Pneumonia 6 6
Respiratory Distress 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Asthma 5 6
Bronchospasm 5 5
Respiratory Insufficiency 4 4
Unspecified Infection 4 4
Arrhythmia 3 3
Hypoxia 3 3
Cough 3 3
Itching Sensation 3 3
Cyanosis 3 3
Increased Respiratory Rate 3 3
No Code Available 3 3
Headache 3 3
Apnea 3 3
Bacterial Infection 3 3
Fibrosis 2 2
Cardiopulmonary Arrest 2 2
Pulmonary Emphysema 2 2
Hypersensitivity/Allergic reaction 2 2
Heart Failure/Congestive Heart Failure 2 2
Chest Pain 2 2
Bradycardia 2 2
Bronchitis 2 2
Sore Throat 2 2
Rash 2 2
Burn(s) 2 2
Respiratory Failure 2 2
Airway Obstruction 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Death 2 2
Pulmonary Edema 2 2
Muscle Weakness/Atrophy 2 2
Pneumothorax 2 2
Decreased Respiratory Rate 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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