Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANKIND PHARMA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JERMEI MEDICAL DEVICE 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
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 113 113
Break 58 58
Defective Device 40 42
Connection Problem 31 31
Therapeutic or Diagnostic Output Failure 28 28
Adverse Event Without Identified Device or Use Problem 26 26
Use of Device Problem 26 26
Mechanical Problem 25 25
Leak/Splash 24 24
Insufficient Information 19 19
Disconnection 17 17
Melted 17 17
Patient Device Interaction Problem 16 16
Failure to Infuse 16 16
Output Problem 16 16
Infusion or Flow Problem 15 15
Improper Flow or Infusion 15 16
Smoking 13 14
Obstruction of Flow 13 23
Fluid/Blood Leak 12 12
Fire 12 12
Increase in Pressure 11 11
Detachment of Device or Device Component 11 21
Component Missing 10 12
Gas/Air Leak 9 9
Failure to Power Up 9 9
Loose or Intermittent Connection 9 9
Defective Component 9 9
Insufficient Flow or Under Infusion 9 10
Unexpected Shutdown 8 8
Appropriate Term/Code Not Available 8 8
Overheating of Device 6 6
Electrical /Electronic Property Problem 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Partial Blockage 5 5
Restricted Flow rate 5 5
Unexpected Therapeutic Results 5 5
Thermal Decomposition of Device 5 5
No Flow 5 15
Degraded 5 5
Sparking 5 5
Contamination 5 5
Temperature Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Failure to Charge 5 5
Product Quality Problem 4 14
Charging Problem 4 4
Protective Measures Problem 4 5
Material Too Soft/Flexible 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 403 419
Insufficient Information 141 141
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 18 18
Dyspnea 18 19
No Patient Involvement 14 14
Unspecified Respiratory Problem 11 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Bronchospasm 4 4
Asthma 4 5
Pneumonia 4 4
Unspecified Infection 3 3
Cyanosis 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
No Information 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Itching Sensation 3 3
Bronchitis 2 2
Decreased Respiratory Rate 2 2
Airway Obstruction 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Emphysema 2 2
Muscle Weakness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Apnea 2 2
Sleep Dysfunction 2 3
Pulmonary Hypertension 2 2
Burning Sensation 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
-
-