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 6
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
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 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
  1.  K192724  Propeller Sensor for Symbicort
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
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 107 107
2024 102 103
2025 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 167 167
Connection Problem 55 55
Leak/Splash 45 45
Break 35 35
Use of Device Problem 26 26
Defective Device 26 26
Disconnection 23 23
Mechanical Problem 22 22
Adverse Event Without Identified Device or Use Problem 22 22
Insufficient Information 19 19
Fluid/Blood Leak 18 18
Therapeutic or Diagnostic Output Failure 15 15
Improper Flow or Infusion 15 15
Melted 15 15
Failure to Infuse 14 14
Infusion or Flow Problem 13 13
Output Problem 13 13
Smoking 12 12
Fire 12 12
Patient Device Interaction Problem 11 11
Defective Component 10 10
Material Rupture 10 10
Gas/Air Leak 9 9
Insufficient Flow or Under Infusion 9 10
Electrical /Electronic Property Problem 9 9
Detachment of Device or Device Component 8 8
Appropriate Term/Code Not Available 8 8
Overheating of Device 8 8
Failure to Power Up 8 8
Fitting Problem 8 8
Inaccurate Delivery 7 7
No Flow 7 7
Thermal Decomposition of Device 6 6
Unexpected Shutdown 6 6
Loose or Intermittent Connection 6 6
Component Missing 6 6
Degraded 6 6
Material Integrity Problem 5 5
Sparking 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Temperature Problem 5 5
Product Quality Problem 4 4
Device Emits Odor 4 4
Partial Blockage 4 4
Unexpected Therapeutic Results 4 4
Material Too Soft/Flexible 4 4
Improper or Incorrect Procedure or Method 4 4
Failure to Charge 4 4
Restricted Flow rate 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 345
No Consequences Or Impact To Patient 149 149
Insufficient Information 91 91
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 52 52
Low Oxygen Saturation 18 18
Dyspnea 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Unintended Extubation 5 5
Dizziness 5 5
Respiratory Insufficiency 4 4
No Information 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Unspecified Infection 3 3
Cyanosis 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Increased Respiratory Rate 3 3
Asthma 3 3
Itching Sensation 3 3
Airway Obstruction 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Hypoxia 2 2
Bronchospasm 2 2
Cough 2 2
Pneumonia 2 2
Bradycardia 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Hypertension 2 2
Apnea 2 2
Muscle Weakness 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Respiratory Distress 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Low Blood Pressure/ Hypotension 1 1
Sleep Dysfunction 1 1
High Blood Pressure/ Hypertension 1 1
Hot Flashes/Flushes 1 1
Death 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
-
-