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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
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
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
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 161 161
2022 55 55
2023 107 107
2024 102 103
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 105 105
Break 33 33
Connection Problem 30 30
Mechanical Problem 22 22
Leak/Splash 17 17
Disconnection 17 17
Use of Device Problem 17 17
Insufficient Information 15 15
Defective Device 15 15
Failure to Infuse 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Improper Flow or Infusion 13 13
Fire 12 12
Output Problem 12 12
Infusion or Flow Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Patient Device Interaction Problem 11 11
Melted 10 10
Fluid/Blood Leak 10 10
Smoking 8 8
Detachment of Device or Device Component 8 8
Failure to Power Up 7 7
Appropriate Term/Code Not Available 7 7
Defective Component 6 6
Insufficient Flow or Under Infusion 6 7
Unexpected Shutdown 6 6
Overheating of Device 6 6
Gas/Air Leak 6 6
Electrical /Electronic Property Problem 6 6
Loose or Intermittent Connection 6 6
Contamination 5 5
No Flow 5 5
Component Missing 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Sparking 4 4
Temperature Problem 4 4
Product Quality Problem 4 4
Degraded 4 4
Material Integrity Problem 4 4
Unexpected Therapeutic Results 4 4
Thermal Decomposition of Device 3 3
Pressure Problem 3 3
Inaccurate Delivery 3 3
Partial Blockage 3 3
Device Displays Incorrect Message 3 3
Obstruction of Flow 3 3
Material Rupture 3 3
Protective Measures Problem 2 2
Separation Problem 2 2
Incomplete or Inadequate Connection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 300 301
Insufficient Information 76 76
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 14 14
No Patient Involvement 14 14
Dyspnea 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Aspiration/Inhalation 5 5
Unintended Extubation 5 5
Respiratory Insufficiency 4 4
Swelling/ Edema 4 4
Dizziness 3 3
Arrhythmia 3 3
Asthma 3 3
Increased Respiratory Rate 3 3
Cyanosis 3 3
Headache 3 3
No Information 3 3
Pneumothorax 2 2
Pneumonia 2 2
Itching Sensation 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Pulmonary Hypertension 2 2
Cough 2 2
Fibrosis 2 2
Bronchospasm 2 2
Unspecified Infection 2 2
Hypoxia 2 2
Hypersensitivity/Allergic reaction 2 2
Chest Pain 2 2
Burn(s) 2 2
Bacterial Infection 2 2
Apnea 2 2
Airway Obstruction 2 2
Partial thickness (Second Degree) Burn 1 1
Heart Failure/Congestive Heart Failure 1 1
Missed Dose 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Wheezing 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Ulcer 1 1
Malaise 1 1
Low Blood Pressure/ Hypotension 1 1
Fatigue 1 1
Decreased Respiratory Rate 1 1

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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