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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
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 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
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K170886  HOMED Mesh Nebulizer
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 107 107
2024 102 103
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 195 195
Connection Problem 70 70
Leak/Splash 63 63
Disconnection 46 46
Break 40 40
Mechanical Problem 24 24
Fluid/Blood Leak 23 23
Fitting Problem 23 23
Adverse Event Without Identified Device or Use Problem 21 21
Defective Device 19 19
Electrical /Electronic Property Problem 19 19
Use of Device Problem 18 18
Insufficient Information 18 18
Improper Flow or Infusion 17 17
Infusion or Flow Problem 15 15
Output Problem 15 15
Gas/Air Leak 14 14
Material Rupture 14 14
Failure to Infuse 14 14
Therapeutic or Diagnostic Output Failure 13 13
Melted 13 13
Fire 13 13
No Flow 13 13
Detachment of Device or Device Component 12 12
Patient Device Interaction Problem 12 12
Defective Component 11 11
Overheating of Device 9 9
Inaccurate Delivery 9 9
Insufficient Flow or Under Infusion 8 9
Smoking 8 8
Degraded 8 8
Failure to Power Up 8 8
Appropriate Term/Code Not Available 7 7
Loose or Intermittent Connection 7 7
Unexpected Shutdown 6 6
Obstruction of Flow 6 6
Improper or Incorrect Procedure or Method 5 5
Material Integrity Problem 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Sparking 5 5
Component Missing 5 5
Unexpected Therapeutic Results 4 4
Device Operates Differently Than Expected 4 4
Product Quality Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Thermal Decomposition of Device 4 4
Temperature Problem 4 4
Device Emits Odor 3 3
Partial Blockage 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 316 317
No Consequences Or Impact To Patient 231 231
No Known Impact Or Consequence To Patient 93 93
Insufficient Information 81 81
No Patient Involvement 80 80
Low Oxygen Saturation 16 16
Dyspnea 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 8 8
No Information 8 8
Respiratory Distress 6 6
Unintended Extubation 5 5
Swelling/ Edema 5 5
Dizziness 5 5
Aspiration/Inhalation 5 5
Respiratory Insufficiency 4 4
Asthma 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Cyanosis 3 3
Unspecified Infection 3 3
Apnea 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
No Code Available 3 3
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Pneumonia 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
Bradycardia 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Muscle Weakness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Death 2 2
Pulmonary Hypertension 2 2
Right Ventricular Dysfunction 1 1
Burning Sensation 1 1
Chemical Exposure 1 1
Burn, Thermal 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
5 Valeant Pharmacueticals International II Jan-17-2018
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