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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)
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHERIUM (NZ) LTD
  SUBSTANTIALLY EQUIVALENT 9
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
  1.  K220145  Monaghan medical filtered mouthpiece kit
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
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 104 104
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 188 188
Connection Problem 70 70
Leak/Splash 62 62
Disconnection 46 46
Break 40 40
Fluid/Blood Leak 23 23
Fitting Problem 23 23
Defective Device 19 19
Mechanical Problem 18 18
Electrical /Electronic Property Problem 17 17
Use of Device Problem 17 17
Improper Flow or Infusion 16 16
Output Problem 15 15
Gas/Air Leak 14 14
Material Rupture 14 14
Fire 13 13
No Flow 13 13
Therapeutic or Diagnostic Output Failure 13 13
Insufficient Information 13 13
Infusion or Flow Problem 12 12
Patient Device Interaction Problem 11 11
Defective Component 11 11
Detachment of Device or Device Component 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Appropriate Term/Code Not Available 7 7
Degraded 7 7
Loose or Intermittent Connection 6 6
Overheating of Device 6 6
Failure to Power Up 6 6
Smoking 6 6
Inaccurate Delivery 6 6
Obstruction of Flow 6 6
Unexpected Shutdown 6 6
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Component Missing 5 5
Sparking 5 5
Melted 5 5
Contamination 5 5
Product Quality Problem 4 4
Device Operates Differently Than Expected 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Noise, Audible 3 3
Insufficient Flow or Under Infusion 3 3
Device Displays Incorrect Message 3 3
Charging Problem 3 3
Corroded 3 3
Display or Visual Feedback Problem 3 3
Thermal Decomposition of Device 3 3
Off-Label Use 3 3
Device Emits Odor 3 3
Burst Container or Vessel 2 2
Detachment Of Device Component 2 2
Incomplete or Missing Packaging 2 2
Malposition of Device 2 2
Complete Loss of Power 2 2
Material Split, Cut or Torn 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
Electrical Shorting 2 2
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 2 2
No Pressure 2 2
Packaging Problem 2 2
Separation Problem 2 2
Power Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Human-Device Interface Problem 1 1
Explosion 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Inappropriate Audible Prompt/Feedback 1 1
Device Damaged Prior to Use 1 1
Difficult or Delayed Activation 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Material Separation 1 1
Component Falling 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 236 236
No Consequences Or Impact To Patient 231 231
No Known Impact Or Consequence To Patient 93 93
No Patient Involvement 80 80
Insufficient Information 58 58
Low Oxygen Saturation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Dyspnea 8 8
Unspecified Respiratory Problem 7 7
Respiratory Distress 6 6
Aspiration/Inhalation 5 5
Unintended Extubation 5 5
Asthma 4 4
Apnea 3 3
Dizziness 3 3
Swelling/ Edema 3 3
Bronchospasm 3 3
No Code Available 3 3
Fibrosis 2 2
Cough 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Urinary Frequency 2 2
Sore Throat 2 2
Increased Respiratory Rate 2 2
Death 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Pneumonia 2 2
Pneumothorax 2 2
Arrhythmia 2 2
Airway Obstruction 2 2
Headache 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Burn(s) 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 1 1
Cyanosis 1 1
Hemorrhage/Bleeding 1 1
Fatigue 1 1
Abrasion 1 1
Pulmonary Edema 1 1
Rash 1 1
Laceration(s) 1 1
Occlusion 1 1
Peeling 1 1
Low Blood Pressure/ Hypotension 1 1
Right Ventricular Dysfunction 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Sleep Dysfunction 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Underdose 1 1
Electric Shock 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Ulcer 1 1
Decreased Respiratory Rate 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Wheezing 1 1
Respiratory Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Skin Inflammation/ Irritation 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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