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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
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201397  Ultrasonic Mesh Nebulizer
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 17 17

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
Fitting Problem 23 23
Fluid/Blood Leak 23 23
Electrical /Electronic Property Problem 19 19
Defective Device 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Insufficient Information 18 18
Use of Device Problem 18 18
Improper Flow or Infusion 17 17
Infusion or Flow Problem 15 15
Output Problem 15 15
Failure to Infuse 14 14
Material Rupture 14 14
Gas/Air Leak 14 14
No Flow 13 13
Fire 13 13
Therapeutic or Diagnostic Output Failure 13 13
Patient Device Interaction Problem 12 12
Detachment of Device or Device Component 12 12
Defective Component 11 11
Melted 10 10
Overheating of Device 9 9
Inaccurate Delivery 9 9
Failure to Power Up 8 8
Smoking 8 8
Loose or Intermittent Connection 7 7
Degraded 7 7
Appropriate Term/Code Not Available 7 7
Unexpected Shutdown 6 6
Insufficient Flow or Under Infusion 6 7
Obstruction of Flow 6 6
Contamination 5 5
Component Missing 5 5
Sparking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Thermal Decomposition of Device 4 4
Device Operates Differently Than Expected 4 4
Temperature Problem 4 4
Unexpected Therapeutic Results 4 4
Product Quality Problem 4 4
Device Displays Incorrect Message 3 3
Device Emits Odor 3 3
Display or Visual Feedback Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 300 301
No Consequences Or Impact To Patient 231 231
No Known Impact Or Consequence To Patient 93 93
No Patient Involvement 80 80
Insufficient Information 76 76
Low Oxygen Saturation 16 16
Dyspnea 12 12
No Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Respiratory Distress 6 6
Unintended Extubation 5 5
Aspiration/Inhalation 5 5
Respiratory Insufficiency 4 4
Swelling/ Edema 4 4
Dizziness 4 4
Asthma 4 4
No Code Available 3 3
Increased Respiratory Rate 3 3
Bronchospasm 3 3
Unspecified Infection 3 3
Pneumonia 3 3
Headache 3 3
Cyanosis 3 3
Apnea 3 3
Arrhythmia 3 3
Pulmonary Hypertension 2 2
Cough 2 2
Fibrosis 2 2
Hypoxia 2 2
Hypersensitivity/Allergic reaction 2 2
Death 2 2
Chest Pain 2 2
Cardiopulmonary Arrest 2 2
Burn(s) 2 2
Bradycardia 2 2
Bacterial Infection 2 2
Airway Obstruction 2 2
Pneumothorax 2 2
Itching Sensation 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Abrasion 1 1
Hot Flashes/Flushes 1 1
Burning Sensation 1 1
Tachycardia 1 1
Right Ventricular Dysfunction 1 1
Rash 1 1
Pulmonary Edema 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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