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
FINDAIR SP. Z O.O.
  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
  1.  K202171  Pulmogine Vibrating Mesh Nebulizer
  2.  K250583  AdheResp Smart Breath-actuated Mesh Nebulizer
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
2019 185 189
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 175 175

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 163 163
Connection Problem 57 57
Infusion or Flow Problem 48 48
Leak/Splash 44 44
Disconnection 24 24
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Fluid/Blood Leak 17 17
Melted 17 17
Insufficient Device Problem Information 15 15
Failure to Infuse 14 14
Insufficient Heating 14 14
Mechanical Problem 13 13
Obstruction of Flow 12 12
Break 12 12
Improper Flow or Infusion 12 12
Smoking 12 13
Increase in Pressure 11 11
Gas/Air Leak 10 10
Material Rupture 10 10
Insufficient Flow or Under Infusion 9 10
Defective Device 9 9
Fire 9 9
Overheating of Device 9 9
Fitting Problem 8 8
Electrical /Electronic Property Problem 8 8
Loose or Intermittent Connection 8 8
Failure to Power Up 7 7
Appropriate Device Problem Term/Code Not Available 6 6
Output Problem 6 6
Inaccurate Delivery 6 6
Sparking 6 6
No Flow 6 6
Material Integrity Problem 6 6
Thermal Decomposition of Device 6 6
Degraded 6 6
Unexpected Shutdown 5 5
Patient Device Interaction Problem 5 5
Defective Component 5 5
Unexpected Therapeutic Results 4 4
Material Too Soft/Flexible 4 4
No Device Output 4 4
Temperature Problem 4 4
Restricted Flow rate 4 4
Partial Blockage 4 4
Detachment of Device or Device Component 4 4
Material Split, Cut or Torn 3 3
Improper or Incorrect Procedure or Method 3 3
Component Missing 3 3
Device Emits Odor 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 520 536
Insufficient Information 166 166
No Consequences Or Impact To Patient 149 149
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 21 21
Dyspnea 18 19
Unspecified Respiratory Problem 16 18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Pneumonia 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Dizziness 5 5
No Information 4 4
Asthma 4 5
Respiratory Insufficiency 4 4
Unspecified Infection 4 4
Bronchospasm 4 4
Arrhythmia 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Headache 3 3
Cyanosis 3 3
Bacterial Infection 3 3
Itching Sensation 3 3
Hypoxia 3 3
Fibrosis 2 2
Rash 2 2
Bradycardia 2 2
Hypersensitivity/Allergic reaction 2 2
Heart Failure/Congestive Heart Failure 2 2
Chest Pain 2 2
Pulmonary Emphysema 2 2
Pulmonary Edema 2 2
Sore Throat 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Burn(s) 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Bronchitis 2 2
Sleep Dysfunction 2 3
Viral Infection 2 2
Airway Obstruction 2 2
Pulmonary Hypertension 2 2
Muscle Weakness/Atrophy 2 2
Urinary Frequency / Polyuria 2 2

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
-
-