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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
  1.  K240840  Oxygen Concentrator (ZY-10AB/115)
FOSHAN KYCARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 5
SHENZHEN HARVEYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 616 616
2026 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 229 243
Adverse Event Without Identified Device or Use Problem 183 183
Fire 169 169
Thermal Decomposition of Device 143 143
Insufficient Information 129 133
Low Readings 107 107
Use of Device Problem 96 96
No Flow 95 95
No Audible Alarm 71 71
Temperature Problem 63 63
Output Problem 59 59
Insufficient Flow or Under Infusion 58 58
Melted 57 71
Unexpected Shutdown 56 56
Explosion 54 54
Unexpected Therapeutic Results 53 53
Excessive Heating 50 50
Noise, Audible 46 46
Smoking 46 46
Electrical /Electronic Property Problem 45 45
Device Emits Odor 41 41
Failure to Deliver 35 42
Improper or Incorrect Procedure or Method 34 34
Contamination 32 32
No Apparent Adverse Event 32 32
Power Problem 32 32
Battery Problem 31 32
Material Deformation 30 30
Mechanical Problem 28 28
Improper Flow or Infusion 28 28
Gas Output Problem 27 27
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
Arcing 15 15
Failure to Charge 15 15
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 13 13
Therapeutic or Diagnostic Output Failure 12 18
Electrical Shorting 11 11
Complete Loss of Power 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 1099 1117
Low Oxygen Saturation 170 170
Insufficient Information 160 160
Dyspnea 138 141
Burn(s) 137 137
Hypoxia 73 73
No Consequences Or Impact To Patient 72 72
Unspecified Respiratory Problem 60 60
Partial thickness (Second Degree) Burn 56 56
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 27 27
No Known Impact Or Consequence To Patient 24 31
Superficial (First Degree) Burn 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Full thickness (Third Degree) Burn 21 21
No Patient Involvement 16 16
Pain 16 16
Headache 15 15
Pneumonia 13 14
Dizziness 11 18
Skin Inflammation/ Irritation 10 10
Respiratory Insufficiency 10 10
Swelling/ Edema 10 10
Aspiration/Inhalation 9 9
Patient Problem/Medical Problem 9 9
Hypersensitivity/Allergic reaction 8 8
Loss of consciousness 7 7
Emotional Changes 7 7
Respiratory Failure 7 7
Fall 6 6
Distress 6 6
Discomfort 6 6
No Information 6 6
Cyanosis 6 6
Burning Sensation 6 6
Unspecified Kidney or Urinary Problem 5 5
Respiratory Tract Infection 5 5
Erythema 5 5
Inflammation 5 5
Muscle Weakness 5 5
Cough 5 5
Cognitive Changes 5 5
Unspecified Heart Problem 5 5
Confusion/ Disorientation 5 5
Viral Infection 4 4
Heart Failure/Congestive Heart Failure 4 4
Anxiety 4 4
Myocardial Infarction 4 4
Sleep Dysfunction 4 4
Unspecified Infection 4 5

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
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