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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
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 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 110 110
Break 33 33
Connection Problem 30 30
Use of Device Problem 24 24
Mechanical Problem 22 22
Defective Device 20 20
Adverse Event Without Identified Device or Use Problem 18 18
Leak/Splash 18 18
Disconnection 17 17
Insufficient Information 16 16
Melted 15 15
Failure to Infuse 14 14
Improper Flow or Infusion 13 13
Output Problem 12 12
Fire 12 12
Therapeutic or Diagnostic Output Failure 12 12
Infusion or Flow Problem 11 11
Patient Device Interaction Problem 11 11
Fluid/Blood Leak 10 10
Smoking 10 10
Failure to Power Up 8 8
Insufficient Flow or Under Infusion 8 9
Appropriate Term/Code Not Available 8 8
Detachment of Device or Device Component 8 8
Overheating of Device 6 6
Component Missing 6 6
Electrical /Electronic Property Problem 6 6
Defective Component 6 6
Loose or Intermittent Connection 6 6
Gas/Air Leak 6 6
Unexpected Shutdown 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Material Integrity Problem 5 5
No Flow 5 5
Degraded 5 5
Contamination 5 5
Thermal Decomposition of Device 5 5
Material Too Soft/Flexible 4 4
Temperature Problem 4 4
Sparking 4 4
Unexpected Therapeutic Results 4 4
Restricted Flow rate 4 4
Failure to Charge 4 4
Partial Blockage 4 4
Product Quality Problem 4 4
Material Rupture 3 3
Device Displays Incorrect Message 3 3
Pressure Problem 3 3
Device Emits Odor 3 3
Inaccurate Delivery 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 338 339
Insufficient Information 86 86
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 15 15
Dyspnea 15 15
No Patient Involvement 14 14
Unspecified Respiratory Problem 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 6 6
Unintended Extubation 5 5
Aspiration/Inhalation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Respiratory Insufficiency 4 4
Dizziness 4 4
No Information 3 3
Headache 3 3
Cyanosis 3 3
Bacterial Infection 3 3
Asthma 3 3
Arrhythmia 3 3
Itching Sensation 3 3
Increased Respiratory Rate 3 3
Pneumonia 2 2
Pneumothorax 2 2
Rash 2 2
Pulmonary Hypertension 2 2
Cough 2 2
Airway Obstruction 2 2
Apnea 2 2
Muscle Weakness 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Burn(s) 2 2
Chest Pain 2 2
Sore Throat 2 2
Bronchospasm 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Unspecified Infection 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Viral Infection 1 1
Wheezing 1 1
Ulcer 1 1
Respiratory Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Partial thickness (Second Degree) Burn 1 1
Malaise 1 1
Missed Dose 1 1
Fungal Infection 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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