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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
  1.  K192971  Nebulizer Kit
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, 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
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 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 115 115
Break 64 64
Defective Device 46 48
Therapeutic or Diagnostic Output Failure 33 33
Connection Problem 32 32
Use of Device Problem 29 29
Adverse Event Without Identified Device or Use Problem 27 27
Mechanical Problem 26 26
Leak/Splash 25 25
Insufficient Information 19 19
Output Problem 19 19
Disconnection 17 17
Infusion or Flow Problem 17 17
Melted 17 17
Patient Device Interaction Problem 16 16
Failure to Infuse 16 16
Improper Flow or Infusion 15 16
Fluid/Blood Leak 15 15
Smoking 14 15
Obstruction of Flow 14 24
Fire 12 12
Detachment of Device or Device Component 12 22
Increase in Pressure 11 11
Defective Component 10 10
Gas/Air Leak 10 10
Component Missing 10 12
Loose or Intermittent Connection 9 9
Insufficient Flow or Under Infusion 9 10
Failure to Power Up 9 9
Unexpected Shutdown 8 8
Appropriate Term/Code Not Available 8 8
Overheating of Device 7 7
Electrical /Electronic Property Problem 6 6
No Flow 6 16
Material Integrity Problem 6 6
Fitting Problem 6 6
Unexpected Therapeutic Results 5 5
Restricted Flow rate 5 5
Partial Blockage 5 5
Sparking 5 5
Contamination 5 5
Thermal Decomposition of Device 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Temperature Problem 5 5
Degraded 5 5
Failure to Charge 5 5
Material Too Soft/Flexible 4 4
Protective Measures Problem 4 5
Inaccurate Delivery 4 4
Crack 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 427 443
Insufficient Information 151 151
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
No Patient Involvement 14 14
Unspecified Respiratory Problem 12 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Pneumonia 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Bronchospasm 4 4
Asthma 4 5
Cyanosis 3 3
Unspecified Infection 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
No Information 3 3
Hypoxia 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Decreased Respiratory Rate 2 2
Respiratory Failure 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Muscle Weakness 2 2
Pulmonary Emphysema 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Pulmonary Hypertension 2 2
Sleep Dysfunction 2 3

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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