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
FINDAIR SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211560  Airvo Nebulizer Adapter
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 485 501

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 112 112
Infusion or Flow Problem 70 70
No Flow 42 42
Connection Problem 35 35
Restricted Flow rate 32 32
Break 30 30
Fluid/Blood Leak 29 29
Pressure Problem 28 28
Adverse Event Without Identified Device or Use Problem 28 28
Leak/Splash 27 27
Use of Device Problem 24 24
Disconnection 21 21
Insufficient Heating 21 37
Fitting Problem 19 19
Decrease in Pressure 19 19
Melted 19 19
Detachment of Device or Device Component 19 19
Output Problem 16 16
Crack 16 16
Failure to Power Up 16 16
Loose or Intermittent Connection 15 15
Insufficient Device Problem Information 15 15
Mechanical Problem 15 15
Gas/Air Leak 14 14
Failure to Infuse 14 14
Obstruction of Flow 13 13
Smoking 13 14
Improper Flow or Infusion 11 11
Defective Device 11 11
Increase in Pressure 11 11
Noise, Audible 10 10
Insufficient Flow or Under Infusion 10 11
Overheating of Device 10 10
Fire 9 9
Electrical /Electronic Property Problem 8 24
Unexpected Shutdown 7 7
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Contamination 6 6
Therapeutic or Diagnostic Output Failure 6 6
Gas Output Problem 6 6
Damaged Thread 5 21
Patient Device Interaction Problem 5 5
Degraded 5 5
Packaging Problem 5 5
No Pressure 5 5
Component Missing 5 5
Output below Specifications 5 5
Sparking 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 809 841
Insufficient Information 177 177
No Consequences Or Impact To Patient 52 52
Low Oxygen Saturation 24 24
No Known Impact Or Consequence To Patient 23 23
Dyspnea 18 19
Unspecified Respiratory Problem 17 19
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Bronchospasm 9 9
Pneumonia 7 7
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Chronic Obstructive Pulmonary Disease (COPD) 6 6
Unintended Extubation 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Asthma 4 5
Cyanosis 3 3
Unspecified Infection 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
No Information 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Decreased Respiratory Rate 2 2
Respiratory Failure 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 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
Urinary Frequency / Polyuria 2 2
Pulmonary Emphysema 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Pulmonary Hypertension 2 2
Sleep Dysfunction 2 3
Muscle Weakness/Atrophy 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Smiths Medical ASD Inc. II Apr-29-2021
-
-