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
FOSHAN CARE MEDICAL TECHNOLOGY 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 2
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 1
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 125 143
2021 194 194
2022 305 308
2023 357 361
2024 450 450
2025 499 499

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 189 203
Adverse Event Without Identified Device or Use Problem 147 147
Fire 134 134
Insufficient Information 122 126
Thermal Decomposition of Device 115 115
Low Readings 107 107
Use of Device Problem 87 87
No Flow 86 86
No Audible Alarm 70 70
Temperature Problem 60 60
Output Problem 58 58
Explosion 48 48
Melted 46 60
Electrical /Electronic Property Problem 45 45
Insufficient Flow or Under Infusion 43 43
Unexpected Therapeutic Results 41 41
Smoking 40 40
Device Emits Odor 39 39
Noise, Audible 39 39
Unexpected Shutdown 38 38
Excessive Heating 37 37
Power Problem 32 32
Contamination 32 32
Material Deformation 29 29
Improper or Incorrect Procedure or Method 28 28
Improper Flow or Infusion 28 28
Battery Problem 27 28
No Apparent Adverse Event 26 26
Gas Output Problem 25 25
Mechanical Problem 25 25
Failure to Deliver 25 25
Infusion or Flow Problem 23 23
Crack 20 20
Failure to Power Up 20 20
Degraded 20 20
Particulates 19 19
Device Alarm System 18 18
Appropriate Term/Code Not Available 16 16
Sparking 16 16
Gas/Air Leak 13 13
Failure to Charge 13 13
Therapeutic or Diagnostic Output Failure 12 18
Device Contamination with Chemical or Other Material 12 12
Material Integrity Problem 11 11
Complete Loss of Power 11 11
Defective Alarm 10 10
Electrical Shorting 9 9
Defective Component 9 9
Arcing 9 9
Break 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1020 1038
Insufficient Information 147 147
Low Oxygen Saturation 138 138
Burn(s) 120 120
Dyspnea 120 123
Hypoxia 72 72
Unspecified Respiratory Problem 55 55
Partial thickness (Second Degree) Burn 50 50
No Consequences Or Impact To Patient 37 37
Chronic Obstructive Pulmonary Disease (COPD) 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Death 18 18
Full thickness (Third Degree) Burn 18 18
Superficial (First Degree) Burn 16 16
Pain 15 15
Headache 13 13
No Known Impact Or Consequence To Patient 12 16
Pneumonia 11 12
No Patient Involvement 11 11
Swelling/ Edema 10 10
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Hypersensitivity/Allergic reaction 8 8
Dizziness 8 8
Respiratory Failure 7 7
Emotional Changes 7 7
Respiratory Insufficiency 6 6
Distress 6 6
Discomfort 6 6
Loss of consciousness 5 5
Erythema 5 5
Cognitive Changes 5 5
Muscle Weakness 5 5
No Information 5 5
Respiratory Tract Infection 5 5
Unspecified Kidney or Urinary Problem 5 5
Unspecified Heart Problem 5 5
Inflammation 4 4
Viral Infection 4 4
Fall 4 4
Burning Sensation 4 4
Heart Failure/Congestive Heart Failure 4 4
Anxiety 4 4
Cough 4 4
Sleep Dysfunction 4 4
Laceration(s) 3 3
Epistaxis 3 3
Myocardial Infarction 3 3
Confusion/ Disorientation 3 3
Itching Sensation 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 DeVilbiss Healthcare LLC II May-04-2023
5 DeVilbiss Healthcare LLC II Dec-19-2022
6 DeVilbiss Healthcare LLC II Nov-11-2022
7 Invacare Corporation III Jul-12-2022
8 Invacare Corporation II Dec-01-2020
9 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
10 Medical Depot Inc. I May-09-2025
11 Ohio Medical Corporation II Jun-13-2025
12 Philips Respironics, Inc. II Nov-07-2025
-
-