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 generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BELLUSCURA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAIRE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN KYCARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOGEN
  SUBSTANTIALLY EQUIVALENT 1
INOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT& SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MOLECULAR PRODUCTS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 120 130
2020 125 143
2021 194 194
2022 305 308
2023 357 361
2024 450 450
2025 558 558

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 209 223
Adverse Event Without Identified Device or Use Problem 177 177
Fire 165 165
Insufficient Information 126 130
Thermal Decomposition of Device 125 125
Low Readings 107 107
Use of Device Problem 91 91
No Flow 89 89
No Audible Alarm 71 71
Temperature Problem 63 63
Output Problem 58 58
Explosion 53 53
Melted 52 66
Unexpected Shutdown 49 49
Insufficient Flow or Under Infusion 48 48
Noise, Audible 45 45
Electrical /Electronic Property Problem 45 45
Unexpected Therapeutic Results 45 45
Excessive Heating 43 43
Smoking 42 42
Device Emits Odor 41 41
Failure to Deliver 33 40
Improper or Incorrect Procedure or Method 33 33
Contamination 32 32
No Apparent Adverse Event 32 32
Power Problem 32 32
Material Deformation 30 30
Battery Problem 30 31
Improper Flow or Infusion 28 28
Mechanical Problem 27 27
Gas Output Problem 26 26
Infusion or Flow Problem 25 25
Device Alarm System 22 22
Crack 20 20
Degraded 20 20
Failure to Power Up 20 20
Particulates 19 19
Sparking 17 17
Appropriate Term/Code Not Available 16 16
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 13 13
Failure to Charge 13 13
Therapeutic or Diagnostic Output Failure 12 18
Electrical Shorting 11 11
Complete Loss of Power 11 11
Arcing 11 11
Material Integrity Problem 11 11
Defective Alarm 10 10
Defective Component 10 10
Disconnection 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1050 1068
Low Oxygen Saturation 160 160
Insufficient Information 150 150
Burn(s) 134 134
Dyspnea 124 127
Hypoxia 72 72
No Consequences Or Impact To Patient 72 72
Unspecified Respiratory Problem 55 55
Partial thickness (Second Degree) Burn 54 54
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 31
Superficial (First Degree) Burn 23 23
Full thickness (Third Degree) Burn 21 21
No Patient Involvement 16 16
Pain 15 15
Pneumonia 13 14
Headache 13 13
Swelling/ Edema 10 10
Dizziness 10 17
Patient Problem/Medical Problem 9 9
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Hypersensitivity/Allergic reaction 8 8
Loss of consciousness 7 7
Respiratory Failure 7 7
Emotional Changes 7 7
No Information 6 6
Discomfort 6 6
Distress 6 6
Respiratory Insufficiency 6 6
Burning Sensation 6 6
Cough 5 5
Inflammation 5 5
Unspecified Heart Problem 5 5
Muscle Weakness 5 5
Unspecified Kidney or Urinary Problem 5 5
Cognitive Changes 5 5
Respiratory Tract Infection 5 5
Erythema 5 5
Sleep Dysfunction 4 4
Myocardial Infarction 4 4
Anxiety 4 4
Heart Failure/Congestive Heart Failure 4 4
Unspecified Infection 4 5
Fall 4 4
Viral Infection 4 4
Cyanosis 3 3
Convulsion/Seizure 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Nov-15-2024
2 Caire, Inc. II May-19-2022
3 Caire, Inc. II Jan-13-2020
4 Caire, Inc. II Oct-30-2019
5 DeVilbiss Healthcare LLC II May-04-2023
6 DeVilbiss Healthcare LLC II Dec-19-2022
7 DeVilbiss Healthcare LLC II Nov-11-2022
8 Invacare Corporation III Jul-12-2022
9 Invacare Corporation II Dec-01-2020
10 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
11 Medical Depot Inc. I May-09-2025
12 Ohio Medical Corporation II Jun-13-2025
13 Philips Respironics, Inc. II Nov-07-2025
-
-